Industry groups are fighting

Doubt
government regulation by
fomenting scientific uncertainty

By David Michaels
Photographs by Mindy Jones

Is Their Product
F
ew scientific challenges are more complex than vinyl chloride, chromium, benzene, benzidine, nickel, and a
understanding the health risks of a chemical or long list of other toxic chemicals and medications. What is
drug. Investigators cannot feed toxic compounds more, Congress and the administration of President George
to people to see what doses cause cancer. Instead W. Bush have encouraged such tactics by making it easier for
laboratory researchers rely on animal tests, and private groups to challenge government-funded research. Al-
epidemiologists examine the human exposures that have al- though in some cases, companies may be raising legitimate
ready happened in the field. Both types of studies have many arguments, the overall result is disturbing: many corporations
uncertainties, and scientists must extrapolate from the evi- have successfully avoided expense and inconvenience by block-
dence to make causal inferences and recommend protective ing and stalling much needed protections for public health.
measures. Because absolute certainty is rarely an option, reg-
ulatory programs would not be effective if such proof were The Taxicab Standard
required. Government officials have to use the best available a g o od e x a m pl e of the current battles between industry
evidence to set limits for harmful chemicals and determine and science is the controversy over beryllium. This lightweight
the safety of pharmaceuticals. metal is vital to the production of nuclear warheads because it
Uncertainty is an inherent problem of science, but manu- increases the yield of the explosions; throughout the cold war,
factured uncertainty is another matter entirely. Over the past the U.S. nuclear weapons complex was the nation’s largest
three decades, industry groups have frequently become involved consumer of the substance. Beryllium and its alloys are now
in the investigative process when their interests are threatened. used to make electronics equipment and even golf clubs. But
If, for example, studies show that a company is exposing its the metal is also extremely toxic— breathing in tiny amounts
workers to dangerous levels of a certain chemical, the business can cause chronic beryllium disease (CBD), a debilitating ail-
typically responds by hiring its own researchers to cast doubt ment that scars the lungs. Victims have included not just the
on the studies. Or if a pharmaceutical firm faces questions about machinists who worked directly with the metal but others sim-
the safety of one of its drugs, its executives trumpet company- ply in the vicinity of the milling and grinding processes, often
sponsored trials that show no significant health risks while for very short periods. One accountant developed CBD after
ignoring or hiding other studies that are much less reassuring. working for a few weeks each year in an office near where
The vilification of threatening research as “junk science” and beryllium was being processed. CBD has also been diagnosed
the corresponding sanctification of industry-commissioned in people living near beryllium factories.
research as “sound science” has become nothing less than stan- As assistant secretary of energy for environment, safety
dard operating procedure in some parts of corporate America. and health from 1998 to 2001, I was the chief safety officer for
In 1969 an executive at Brown & Williamson, a cigarette the nuclear weapons complex, responsible for protecting the
maker now owned by R. J. Reynolds Tobacco Company, un- health of workers at production and research facilities as well
wisely committed to paper the perfect slogan for his industry’s as for safeguarding the surrounding communities and envi-
disinformation campaign: “Doubt is our product since it is the ronment. When President Bill Clinton appointed me, the De-
best means of competing with the ‘body of fact’ that exists in partment of Energy’s exposure standard for beryllium had not
the mind of the general public.” In recent years, many other changed since 1949, some years after the substance’s health
industries have eagerly adopted this strategy. Corporations dangers had become clear. In response to a crisis involving
have mounted campaigns to question studies documenting the many sick workers and community residents, two scientists
adverse health effects of exposure to beryllium, lead, mercury, working with the Atomic Energy Commission estimated what

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 DRUG COMPANIES fund
most of the research on the
health risks of their
products. All too often the
firms highlight studies
showing that the drugs are
safe and downplay less
reassuring results.

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they thought to be a safe level— two micrograms of beryllium
per cubic meter of air— while they were riding in a taxicab on
their way to a meeting. The commission, the predecessor of
the DOE , then implemented the so-called taxicab standard.
When the Occupational Safety and Health Administration
(OSHA) was established in 1971 to protect the health of work-
ers in the private sector, it, too, adopted the taxicab standard
for beryllium. Over the following decades, however, it became
clear that workers exposed to beryllium levels well below the
standard were falling sick. In the 1990s the DOE and OSHA
began the time-consuming legal process of changing their ex-
posure limits for beryllium. Brush Wellman, the nation’s lead-
ing producer of the metal, hired Exponent, a Menlo Park,
Calif., consulting firm specializing in product defense. Sharing
authorship with Brush Wellman’s scientists, these consultants
wrote a series of papers suggesting it was possible that the size,
surface area and number of beryllium particles may be more
important than previously thought in the development of
CBD. They also raised the hypothesis that skin exposure could
play a larger role in disease risk. The consultants concluded
that the current standard for beryllium might not be protective
but that more research was required before changing it.
After reviewing all the studies and taking testimony from
industry and independent scientists, the DOE leadership in the CORPOR ATE HURDLES are impeding the
later years of the Clinton administration decided that although regulation of unsafe chemicals and drugs.
more research is always desirable, the department had more
than enough information to warrant immediate implementa-
tion of a stricter standard for beryllium. We issued a new rule,
reducing the acceptable workplace exposure level by a factor lung cancer so that the elevation caused by beryllium was no
of 10. Although we could not prove that the lower limit would longer statistically significant. (This procedure is rather easily
eliminate the health risks, we chose a level that we believed accomplished, whereas the opposite — turning insignificance
would prevent most cases of CBD and that was also techno- into significance — is extremely difficult.) Brush Wellman and
logically feasible. This new standard, however, applies only to NGK Metals, a producer of beryllium alloys, had funded the
DOE workers; workers in the private sector, who fall under research. The new analysis was published in Inhalation Toxi-
OSHA’s umbrella, do not enjoy the same protection. In 1998 cology, a peer-reviewed journal— not one primarily focused on
OSHA declared its intention to follow DOE’s lead, but three epidemiology but peer-reviewed nonetheless— and the industry
years later the agency dropped that initiative. In November now touts its study as evidence that everyone else is wrong.

Many corporations have avoided expense by

STALLING PROTECTIONS for public health.
2002 the agency implicitly accepted the industry’s arguments This pattern is not unique to the beryllium industry. Many
by issuing a call for additional data on the relation of beryllium other companies that produce hazardous chemicals have hired
disease to, among other things, the size, surface area and num- researchers to dispute and reanalyze data showing adverse
ber of particles and the extent of skin contact. That is where health effects. Their conclusions are almost always the same:
matters stand today. the evidence is ambiguous, so regulatory action is unwarrant-
As it happens, most scientists believe that beryllium also ed. Out of the almost 3,000 chemicals produced in large quan-
increases the risk of lung cancer; several studies conducted by tities (more than one million pounds annually), OSHA enforc-
epidemiologists at the Centers for Disease Control and Preven- es exposure limits for fewer than 500. In the past 10 years the
tion support this conclusion. In 2002, however, statisticians agency has issued new standards for a grand total of two
from another product-defense firm, Roth Associates in Rock- chemicals; the vast majority of the others are still “regulated”
ville, Md., and the University of Illinois published a reanalysis by voluntary standards set before 1971, when the newly created
of a 10-year-old CDC study. By changing some key parameters, agency adopted them uncritically and unchanged. New science
the authors raised the estimates for the background rate of has had no impact on them. I conclude that successive OSHA

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administrators have simply recognized that establishing new who had taken a PPA-containing drug began circulating in the
standards is so time- and labor-intensive, and will inevitably call 1970s. Over the next 20 years, the FDA raised questions about
forth such orchestrated opposition from industry, that it is not PPA’s safety, but the trade association representing the drug’s
worth expending the agency’s limited resources on the effort. manufacturers— including Bayer, Sandoz (now part of Novar-
Emphasizing uncertainty on behalf of big business has be- tis), Wyeth and GlaxoSmithKline — rejected the agency’s con-
come a big business in itself. The product-defense firms have cerns, employing scientists and lobbyists to keep PPA on the
become experienced and successful consultants in epidemiol- market. Eventually a compromise was reached that allowed
ogy, biostatistics and toxicology. In fact, it is now unusual for the companies to select an investigator and fund an epidemio-
the science behind any proposed public health or environmen- logical study whose design would be approved by both the
tal regulation not to be challenged, no matter how powerful manufacturers and the FDA . They chose the Yale University
the evidence. Currently representatives of indoor tanning sa- School of Medicine; in 1999 the study confi rmed that PPA
lons are hard at work disparaging the designation of ultravio- causes hemorrhagic stroke.
let radiation as a cause of skin cancer. Furthermore, the de- Did the manufacturers withdraw the drug, which by then
nial of scientific evidence and the insistence on an impossible had annual sales of more than $500 million? No. Instead they
certainty are not limited to business interests. For instance, turned to the Weinberg Group, a product-defense consulting
some zealous environmentalists remain adamantly opposed firm based in Washington, D.C., to attack the study and had
to food irradiation— the use of gamma rays, x-rays or electron their attorneys put the researchers through grueling legal de-
beams to kill microbes in meats and produce — even though positions. David A. Kessler, former head of the FDA and now
the benefits of the practice greatly outweigh the risks. dean of the University of California at San Francisco School
of Medicine, said, “With the amount of hassle and harassment
PPA and Vioxx that [the Yale scientists] had to endure, I’m sure the next time
t h e p ow e r of c om pa n i e s to influence and distort re- they’re asked to undertake something like this, they’ll wonder
search is also strong in the pharmaceutical industry. Consider if it’s worth the cost.” The FDA finally advised manufacturers
the Food and Drug Administration’s belated clampdown on to stop marketing PPA in November 2000. The agency esti-
phenylpropanolamine (PPA), the over-the-counter drug that mates that the chemical caused between 200 and 500 strokes
was widely used as a decongestant and appetite suppressant a year among 18- to 49-year-old people.
for decades. Reports of hemorrhagic strokes in young women Or consider rofecoxib, more commonly known as Vioxx,

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 GOVERNMENT AGENCIES have been slow to act
even in cases where the evidence for stricter
regulation is overwhelming.

the once popular pain reliever made by Merck. Even before the FDA analyst estimated that Vioxx caused between 88,000 and
FDA approved Vioxx in May 1999, the agency had reviewed 139,000 heart attacks— 30 to 40 percent of which were prob-
data suggesting that the drug could increase the risk of heart ably fatal— in the five years the drug was on the market.
disease. Several independent scientists (that is, ones not on Although the Wall Street Journal has reported that certain
Merck’s payroll) also raised red flags, but for the most part the documents suggest that Merck executives were aware of the
FDA ignored them. Then, in early 2000, the results of a clinical increased risk of heart attacks, it is hard to imagine that the
trial showed that participants who took Vioxx for an average company’s scientists were deliberately promoting a drug they
of nine months had five times the risk of heart attack as those knew was unsafe. At the same time, it is hard to imagine they
taking the comparison painkiller, naproxen (sold under the honestly thought naproxen reduced the risk of heart attack by
brand name Aleve). 80 percent. If they did, they should have urged the government
Merck’s scientists faced a dilemma. They could interpret to pour it straight into the water supply. It seems more likely
this finding to mean either that Vioxx increased heart attack that their allegiances were so tightly linked with the products
risk by 400 percent or that naproxen reduced the risk by an they worked on, as well as the financial health of their employ-
astounding 80 percent, making it about three times as effective ers, that their judgment became fatally impaired. And the
as aspirin in protecting the cardiovascular system. Unsurpris- FDA? That agency has neither the legal authority nor the re-
ingly, the company’s researchers chose the latter interpretation. sources to effectively identify the adverse outcomes caused by
But Merck abruptly turned about and took Vioxx off the mar- drugs already on the market.
ket last September when another trial found that participants As a result, civil lawsuits have become the primary means
taking the drug for more than 18 months suffered twice as for protecting the public from unsafe drugs and chemicals.
many heart attacks and strokes as those taking a placebo. One Recent rulings of the U.S. Supreme Court, however, have made
it harder for plaintiffs to introduce scientific testimony to sup-
THE AUTHOR

DAVID MICHAELS is an epidemiologist who served as the U.S. port their cases. Under the precedents set by Daubert v. Mer-
Department of Energy’s assistant secretary for environment, rell Dow Pharmaceuticals and two related rulings, federal
safety and health from 1998 to 2001. He is currently professor trial judges are now required to determine whether the testi-
and associate chairman in the department of environmental mony is reliable and relevant. What began as a well-inten-
and occupational health at the George Washington University tioned effort to improve the quality of scientific evidence has
School of Public Health and Health Services. had troubling consequences: according to an analysis pub-

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lished in 2002 in the Journal of the American Medical Asso- the Office of Management and Budget (OMB) rolled out a new
ciation, federal judges have barred respected researchers from proposal entitled “Peer Review and Information Quality.”
testifying in drug lawsuits because their evidence — such as Under the plan, all covered information would undergo some
medical case reports and toxicological studies on animals — form of peer review before being issued by a government
did not meet the strict new standards. Corporate defendants agency, and any information that might affect major regula-
have become increasingly emboldened to challenge any expert tions or that could have a “substantial impact” on public
testimony on the grounds that it is based on “junk science.” policies or private-sector decisions would be put through a
cumbersome system in which the information was reviewed
Data Quality by experts independent of the agency. Because the proposed
i n d u s t ry g ro u p s have tried to manipulate science no peer-review process would exclude all scientists receiving
matter which political party controls the government, but the grants or contracts from the agency, it seemed designed to
efforts have grown more brazen since George W. Bush became maximize the ability of corporate interests to manufacture
president. I believe it is fair to say that never in our history have and magnify scientific uncertainty.
corporate interests been as successful as they are today in shap- Enough was enough. In November 2003 the usually qui-
ing science policies to their desires. In 2002, for example, the escent science community finally rose up in protest at a meeting

A new regulatory paradigm is needed, but the Bush

administration is heading in the WRONG DIRECTION.
Bush administration remade a committee that advises the CDC sponsored, at the OMB’s request, by the National Academy of
on the issue of childhood lead poisoning. Secretary of Health Sciences. In the face of this opposition— dozens of organizations
and Human Services Tommy Thompson replaced prominent fired off scathing letters to the White House— the OMB retreat-
researchers with individuals more likely to side with the lead ed and implemented a less onerous program that did not exclude
industry. (One new member had testified on behalf of the lead the most qualified scientists from the peer-review process.
paint industry in a suit brought by the state of Rhode Island to A new regulatory paradigm is clearly needed, but the Bush
recover the costs of treating children with lead poisoning and administration is heading in the wrong direction. Instead of
cleaning contaminated homes.) Since then, the CDC has not encouraging industry groups to revise the reports of govern-
moved to strengthen the federal standards for lead poisoning ment scientists, agencies should be focusing more scrutiny on
despite research showing that even very low levels of lead in the data and analyses provided by corporate scientists and
the blood can sharply reduce a child’s IQ. product-defense fi rms. And instead of allowing uncertainty
What is more, this administration has tried to facilitate and to be an excuse for inaction, regulators should return to first
institutionalize the corporate strategy of manufacturing un- principles: use the best science available but do not demand
certainty. Its most significant tool is the Data Quality Act certainty where it does not exist.
(DQA), a midnight rider attached to a 2001 appropriations bill A good example of such an approach is the program to
and approved by Congress without hearings or debate. The provide compensation for weapons workers sickened after
DQA authorized the development of guidelines for “ensuring exposure to radiation or chemicals at DOE sites. (I helped to
and maximizing the quality, objectivity, utility, and integrity design the initiative, which was enacted by Congress in 2000.)
of information.” This sounds harmless, even beneficial; who Because it is impossible to defi nitively determine whether a
wouldn’t want to ensure the quality of government-dissemi- particular cancer has been caused by radiation exposure, the
nated information? In practice, however, industry groups use program estimates probabilities based on the cancer rates
the DQA to slow or stop attempts at regulation by undercut- among survivors of the nuclear blasts at Hiroshima and Na-
ting scientific reports. The law gives corporations an estab- gasaki. The model is not perfect, but the estimates are as ac-
lished procedure for killing or altering government documents curate as the available data and methods allow.
with which they do not agree. It has been used by groups bank- In that case, we did the right thing. Now it is time for in-
rolled by the oil industry to discredit the National Assessment dustry to do the right thing. We need a better balance between
on Climate Change, a federal report on global warming; by health and money.
food industry interests to attack the World Health Organiza-
tion’s dietary guidelines, which recommend lower sugar intake MORE TO EXPLORE
to prevent obesity; and by the Salt Institute to challenge the Deceit and Denial: The Deadly Politics of Industrial Pollution. Gerald
advice of the National Institutes of Health that Americans Markowitz and David Rosner. University of California Press, 2002.
should reduce their salt consumption. Science for Judges I–III. Edited by Margaret Berger. Journal of Law
and Policy, Vols. 12–13; 2003–2005. Available online at
Even better for industry would be a way to control infor- www.brooklaw.edu/students/journals/jlp.php
mation before it becomes part of an official government doc- More information about the use of scientific evidence in public policy
ument. To accomplish this tantalizing goal, in August 2003 is available at www.DefendingScience.org

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