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Abstract and Figures

This talk's title comes from a tobacco executive's memo: "Doubt is our product since it is the best means of competing with the 'body of fact' that exists in the minds of the general public. It is also the means of establishing a controversy. Although Big Tobacco manufactured more uncertainty over a longer period and more effectively than any other industry, the strategy of manufacturing uncertainty has been used with great success by numerous polluters and manufacturers of dangerous products to oppose public health and environmental regulation. It is central to the debate on global warming, and arises often in considering the safety of drugs and medical devices, and of consumer products. The approach is now so common that it is unusual for an industry not to challenge the science behind any regulation it faces. Manufacturing uncertainty has become a business in itself; numerous technical consulting firms advertise product defense or litigation support. The firms, and the scientists who own and operate them, sell not just their scientific expertise, but their knowledge of and access to regulatory agencies. The financial success of these firms depends on their ability to help their clients avoid increased regulation. Not surprisingly, it is rare for these firms to produce a study whose results conflict with the needs of the study sponsor. It follows that these scientists' financial conflicts of interest are so severe that they should be barred from serving on federal science advisory panels that inform public health policy.
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96 SCIENTIFIC AMERICAN JUNE 2005
F ew scientifi c 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 al-
ready happened in the fi eld. Both types of studies have many
uncertainties, and scientists must extrapolate from the evi-
dence to make causal inferences and recommend protective
measures. Because absolute certainty is rarely an option, reg-
ulatory programs would not be effective if such proof were
required. Government offi cials 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 manu-
factured uncertainty is another matter entirely. Over the past
t hr ee de c ad es , i nd us tr y g roup s h ave f re qu en tl y b ec om e i nvo lv ed
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 cer tain chemical, the business
typically responds by hiring its own researchers to cast doubt
on the studies. Or if a pharmaceutic al fi r m faces questions about
the safety of one of its drugs, its executives trumpet company-
sponsored trials that show no signifi cant health risks while
ignoring or hiding other studies that are much less reassuring.
The vilifi cation of threatening research as “junk science” and
the corresponding sancti cation of industry-commissioned
re se ar ch as “s ou nd sc ie nc e” ha s b ec om e not hi ng le ss t ha n s ta n-
dard 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, un-
wisely 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 encou raged such tactics by making it easier for
private groups to challenge government-funded research. Al-
though in some cases, companies may be raising legitimate
arguments, the overall result is disturbing: many corporations
have successfully avoided expense and inconvenience by block-
ing and stalling much needed protections for public health.
The Taxicab Standard
a good ex a mpl e of the current battles between industry
and science is the controversy over ber yllium. T his lightweight
metal is vital to the production of nuclear warheads because it
increases the yield of the explosions; throughout the cold war,
the U.S. nuclear weapons complex was the nation’s largest
consumer of the substance. Beryllium and its alloys are now
used to make electronics equipment and even golf clubs. But
the metal is also extremely toxicbreathing in tiny amounts
can cause chronic beryllium disease (CBD), a debilitating ail-
ment that scars the lungs. Victims have included not just the
machinists who worked directly with the metal but others sim-
ply in the vicinity of the milling and grinding processes, often
for very short periods. One accountant developed CBD after
working for a few weeks each year in an offi ce near where
beryllium was being processed. CBD has also been diagnosed
in people living near beryllium factories.
As assistant secretary of energy for environment, safety
and health from 1998 to 2001, I was the chief safety offi cer for
the nuclear weapons complex, responsible for protecting the
healt h of worker s at produ ctio n and re sea rch fac ilit ies as wel l
as for safeguarding the surrounding communities and envi-
ronment. When President Bill Clinton appointed me, the De-
partment of Energy’s exposure standard for beryllium had not
changed since 1949, some years after the substance’s health
dangers had become clear. In response to a crisis involving
many sick workers and community residents, two scientists
working with the Atomic Energy Commission estimated what
Industry groups are fi ghting
government regulation by
fomenting scientifi c uncertainty
Is Their Product
Doubt
By David Michaels
Photographs by Mindy Jones
COPYRIGHT 2005 SCIENTIFIC AMERICAN, INC.
www.sciam.com SCIENTIFIC AMERICAN 97
DRUG COMPANIES fund
most of the research on the
health risks of their
produc ts. All too of ten the
rms highlight studies
showing that the drugs are
safe and downplay less
reassuring results.
COPYRIGHT 2005 SCIENTIFIC AMERICAN, INC.
98 SCIENTIFIC AMERICAN JUNE 2005
they thought to be a safe leveltwo micrograms of beryllium
per cubic meter of airwhile 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 fi rm 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
C BD. T he y a ls o r ai se d t he hy pot he si s t ha t s ki n e xp osu re cou ld
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 t he
later years of the Clinton administration decided that althoug h
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
of 10. Although we could not prove that the lower limit would
eliminate the health risks, we chose a level that we believed
would prevent most cases of CBD and that was also techno-
logically feasible. This new standard, however, applies only to
DOE workers; workers in the private sector, who fall under
OSHAs umbrella, do not enjoy the same protection. In 1998
OSHA declared its intention to follow DOE’s lead, but three
years later the agency dropped that initiative. In November
20 02 the age ncy i mplic itly ac cepted the industry’s arguments
by is su in g a ca ll for add it io na l d at a o n t he re la ti on of b er yl li um
disease to, among other things, the size, surface area and num-
ber of particles and the extent of skin contact. That is where
matters stand today.
As it happens, most scientists believe that beryllium also
increases the risk of lung cancer; several studies conducted by
epidemiologists at the Centers for Disease Control and Preven-
tion support this conclusion. In 2002, however, statisticians
from another product-defense fi rm, Roth Associates in Rock-
ville, Md., and the University of Illinois published a reanalysis
of a 10-year-old CDC s tu dy. By ch an gi ng som e key p ar am et er s,
the authors raised the estimates for the background rate of
lung cancer so that the elevation caused by beryllium was no
longer statistically signifi cant. (This procedure is rather easily
accomplished, whereas the oppositeturning insignifi cance
into signifi canceis extremely diffi cult.) Brush Wellman and
NGK Metals, a producer of beryllium alloys, had funded the
research. The new analysis was published in Inhalation Toxi-
cology, a peer-reviewed journalnot one primarily focused on
epidemiolog y but peer-reviewed nonetheless and the industry
now touts its study as evidence that e veryone else is w rong.
This pattern is not unique to the ber yllium industry. Many
other companies that produce hazardous chemicals have hired
researchers to dispute and reanalyze data showing adverse
health effects. Their conclusions are almost always the same:
the evidence is ambiguous, so regulatory action is unwarrant-
ed. Out of the almost 3,0 00 chemicals produced in large quan-
tities (more than one million pounds annually), OSHA enforc-
es exposure limits for fewer than 500. In the past 10 years the
agency has issued new standards for a grand total of two
chemicals; the vast majority of the others are still “regulated”
by voluntary standards set before 1971, when the newly created
agency adopted them uncritically and u nchanged. New science
has had no impact on them. I conclude that successive OSHA
Many corporations have avoided expense by
STALLING PROTECTIONS for public health.
CORPORATE HURDLES are impeding the
regulation of unsafe chemicals and drugs.
COPYRIGHT 2005 SCIENTIFIC AMERICAN, INC.
www.sciam.com SCIENTIFIC AMERICAN 99
administrators have simply recognized that establishing new
standards is so time- and labor-intensive, and will inevitably call
forth such orchestrated opposition from industry, that it is not
worth expending the agency’s limited resources on the effort.
Emphasizing uncertainty on behalf of big business has be-
come a big business in itself. The product-defense fi rms have
become experienced and successful consultants in epidemiol-
ogy, biostatistics and toxicology. In fact, it is now unusual for
the science behind any proposed public health or environmen-
tal regulation not to be challenged, no matter how powerful
the evidence. Currently representatives of indoor tanning sa-
lons are hard at work disparaging the designation of ultravio-
let radiation as a cause of skin cancer. Furthermore, the de-
nial of scientifi c evidence and the insistence on an impossible
certainty are not limited to business interests. For instance,
some zealous environmentalists remain adamantly opposed
to food irradiationthe use of gamma rays, x-rays or electron
beams to kill microbes in meats and produceeven though
the benefi ts of the practice greatly outweigh the risks.
PPA and Vioxx
the p owe r of compan ies to infl uence and distort re-
search is also strong in the pharmaceutical industry. Consider
the Food and Drug Administration’s belated clampdown on
phenylpropanolamine (PPA), the over-the-counter drug that
was widely used as a decongestant and appetite suppressant
for decades. Reports of hemorrhagic strokes in young women
who had taken a PPA-containing drug began circulating in the
1970s. Over the next 20 years, the FDA raised questions about
PPA’s safety, but the trade association representing the drug’s
manufacturersincluding Bayer, Sandoz (now part of Novar-
tis), Wyeth and GlaxoSmithKlinerejected the agency’s con-
cerns, employing scientists and lobbyists to keep PPA on the
market. Eventually a compromise was reached that allowed
the companies to select an investigator and fund an epidemio-
logical study whose design would be approved by both the
manufacturers and the FDA. They chose the Yale University
School of Medicine; in 1999 the study confi rmed that PPA
causes hemorrhagic stroke.
Did the manufacturers withdraw the drug, which by then
had annual sales of more than $500 million? No. Instead they
turned to the Weinberg Group, a product-defense consulting
rm based in Washington, D.C., to attack the study and had
their attorneys put the researchers through grueling legal de-
positions. David A. Kessler, former head of the FDA and now
dean of the University of California at San Francisco School
of Medicine, said, “With the amou nt of hassle and harassment
that [the Yale scientists] had to endure, I’m sure the next time
they’re asked to undertake something like this, they’ll wonder
if it’s worth the cost.” The FDA nally advised manufacturers
to stop marketing PPA in November 2000. The agency esti-
mates that the chemical caused between 200 and 500 strokes
a year among 18- to 49-year-old people.
Or consider rofecoxib, more commonly known as Vioxx,
COPYRIGHT 2005 SCIENTIFIC AMERICAN, INC.
100 SCIENTIFIC AMERICAN JUNE 2005
t he on ce po pu la r p ai n r el ie ve r m ad e b y Merc k. Eve n b ef or e t he
FDA approved Vioxx in May 1999, the agency had reviewed
data suggesting that the drug could increase the risk of heart
disease. Several independent scientists (that is, ones not on
Merck’s payroll) also raised red fl ags, but for the most part the
FDA ignored them. T hen, in early 2000, the results of a clinical
trial showed that participants who took Vioxx for an average
of nine months had fi ve times the risk of heart attack as those
taking the comparison painkiller, naproxen (sold under the
brand name Aleve).
Merck’s scientists faced a dilemma. They could interpret
this fi nding to mean either that Vioxx increased heart attack
risk by 400 percent or that naproxen reduced the risk by an
as tou nd in g 8 0 p er ce nt , m ak in g i t ab out t hr ee ti me s a s ef fe ct iv e
as aspirin in protecting the cardiovascular system. Unsurpris-
ingly, the company’s researchers chose the latter interpretation.
But Merck abruptly turned about and took Vioxx off the mar-
ket last September when another trial found that participants
taking the drug for more than 18 months suffered twice as
many heart attacks and strokes as those taking a placebo. One
FDA analyst estimated that Vioxx caused between 88,000 and
139,000 heart attacks30 to 40 percent of which were prob-
ably fatalin the fi ve years the drug was on the market.
Although the W al l S tr ee t J ou rn al has reported that certain
documents suggest that Merck executives were aware of the
increased risk of heart attacks, it is hard to imagine that the
company’s scientists were deliberately promoting a drug they
knew was unsafe. At the same time, it is hard to imagine they
honestly thought naproxen reduced the risk of heart attack by
80 p er ce nt . I f t he y d id , t he y s ho ul d h ave u rg ed th e g ove rn me nt
to pour it straight into the water supply. It seems more likely
that their allegiances were so tightly linked with the products
t hey worked on , a s wel l a s t he fi nancial health of their employ-
ers, that their judgment became fatally impaired. And the
FDA? That agency has neither the legal authority nor the re-
sources to effectively identify the adverse outcomes caused by
drugs already on the market.
As a result, civil lawsuits have become the primary means
for protecting the public from unsafe drugs and chemicals.
Recent rulings of the U.S. Supreme Court, however, have made
it harder for plaintiffs to introduce scienti c testimony to sup-
port their cases. Under the precedents set by Daubert v. Mer-
rell Dow Pharmaceuticals and two related rulings, federal
trial judges are now required to determine whether the testi-
mony is reliable and relevant. What began as a well-inten-
tioned effort to improve the quality of scienti c evidence has
had troubling consequences: according to an analysis pub-
GOVERNMENT AGENCIES have been slo w to act
even in cases where the evidenc e for stricter
regulation is overw helming.
DAVID MICHAELS is an epidemiologist who served as the U.S.
Department of Ener gy’s assistant secretary for environment,
sa fe ty and he al th f ro m 1 998 to 20 01. He i s c ur re nt ly p ro fe ss or
and associate chairman in the department of environmental
and occupational health at the George Washington University
School of Public Health and Health S ervices.
THE AUTHOR
COPYRIGHT 2005 SCIENTIFIC AMERICAN, INC.
www.sciam.com SCIENTIFIC AMERICAN 101
lished in 2002 in the Journal of the American Medical Asso-
ciation, federal judges have barred respected researchers from
testifying in drug lawsuits because their evidencesuch as
medical case reports and toxicological studies on animals
did not meet the strict new standards. Corporate defendants
have become increasingly emboldened to challenge any expert
testimony on the grounds that it is based on “junk science.”
Data Quality
industry groups have tried to manipulate science no
matter which political party controls the government, but the
efforts have grown more brazen since George W. Bush became
president. I believe it is fair to say that never in our history have
corporate interests been as successful as they are today in shap-
ing science policies to their desires. In 2002, for example, the
Bush administration remade a committee that advises the CDC
on the issue of childhood lead poisoning. Sec retary of Hea lth
and Human Services Tommy Thompson replaced prominent
researchers with individuals more likely to side with the lead
industry. (One new member had testifi ed on behal f of t he lead
paint industry in a suit brought by the state of Rhode Island to
recover the costs of treating children with lead poisoning and
cleaning contaminated homes.) Since then, the CDC has not
moved to strengthen the federal standards for lead poisoning
despite research showing that even very low levels of lead in
the blood can sharply reduce a child’s IQ.
W ha t i s m ore , t hi s a dm i ni st ra ti on ha s t rie d to f ac il it at e a nd
institutionalize the corporate strategy of manufacturing un-
certainty. Its most signifi cant tool is the Data Quality Act
( DQA ), a m id ni gh t r id er at ta ch ed to a 2 00 1 a ppropr iat io ns bi ll
and approved by Congress without hearings or debate. The
DQA authorized the development of guidelines for “ensuring
and maximizing the quality, objectivity, utility, and integrity
of information.” This sounds harmless, even benefi cial; who
wouldn’t want to ensure the quality of government-dissemi-
nated information? In practice, however, industry groups use
the DQA to slow or stop attempts at regulation by undercut-
ting scientifi c reports. The law gives corporations an estab-
lished procedure for killing or altering government documents
w it h w hi ch th ey do not a gr ee . I t h as be en us ed by gr ou ps ba nk -
rolled by the oil industry to discredit the National Assessment
on Climate Change, a federal report on global warming; by
food industry interests to attack the World Health Organiza-
tion’s dietary guidelines, which recommend lower sugar intake
to prevent obesity; and by the Salt Institute to challenge the
advice of the National Institutes of Health that Americans
should reduce their salt consumption.
Even better for industry would be a way to control infor-
mation before it b ecomes part of an of fi cial government doc-
ument. To accomplish this tantalizing goal, in August 2003
the Offi ce of Ma nageme nt a nd B udge t ( OMB) rolled out a new
proposal entitled “Peer Review and Information Quality.”
Under the plan, all covered information would undergo some
form of peer review before being issued by a government
agency, and any information that might affect major regula-
tions or that could have a “substantial impact” on public
policies or private-sector decisions would be put through a
cumbersome system in which the information was reviewed
by experts independent of the agency. Because the proposed
peer-review process would exclude all scientists receiving
grants or contracts from the agency, it seemed designed to
maximize the ability of corporate interests to manufacture
and magnify scientifi c uncertainty.
Enough was enough. In November 2003 the usually qui-
escent science commu nity fi nally rose up in protest at a meet ing
sponsored, at the OMB’s request, by the National Academy of
Sciences. In the face of this oppositiondozens of organi zations
red off scathing let ters to the White House the OMB retreat-
ed and implemented a le ss onerous program that did not exclude
the most qualifi ed scientists from the peer-review process.
A new regulatory paradigm is clearly needed, but the Bush
administration is heading in the wrong direction. Instead of
encouraging industry groups to revise the reports of govern-
ment scie ntis ts , agenc ies shou ld be foc usi ng more sc rut iny on
the data and analyses provided by corporate scientists and
product-defense fi rms. And instead of allowing uncertainty
to be an excuse for inaction, regulators should return to fi rst
principles: use the best science available but do not demand
certainty where it does not exist.
A good example of such an approach is the program to
provide compensation for weapons workers sickened after
exposure to radiation or chemicals at DOE sites. (I helped to
design the initiative, which was enacted by Congress in 2000.)
Because it is impossible to defi nitively determine whether a
particular cancer has been caused by radiation exposure, the
program estimates probabilities based on the cancer rates
among survivors of the nuclear blasts at Hiroshima and Na-
gasaki. The model is not perfect, but the estimates are as ac-
curate as the available data and methods allow.
In that case, we did the right thing. Now it is time for in-
dustry to do the right thing. We need a better balance between
health and money.
MORE TO EXPLORE
Deceit a nd Denial: The Deadly P olitics of Indus trial Pollution . Gerald
Markow itz and David Ros ner. University o f California Pr ess, 2002.
Scienc e for Judges I–II I. Edited by Margaret Berger. Journal of Law
and Policy, Vols. 12–13; 2003–200 5. Available online at
www.brooklaw.edu/students/journals/jlp.php
More inf ormation abou t the use of scienti fi c evidence in publi c policy
is available at www.DefendingScience.org
A new regulatory paradigm is needed, but the Bush
administration is heading in the WRONG DIRECTION.
COPYRIGHT 2005 SCIENTIFIC AMERICAN, INC.
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