Scientific American
June 15, 2005


Industry groups are fighting government regulation by formenting
scientific uncertainty

By David Michaels

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

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.

The Taxicab Standard

A GOOD EXAMPLE of the current battles between industry and science is
the controversy over beryllium. This 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 toxic--breathing in tiny amounts can
cause chronic beryllium disease (CBD), a debilitating ailment that
scars the lungs. Victims have included not just the machinists who
worked directly with the metal but others simply 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
office 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 officer for the nuclear
weapons complex, responsible for protecting the health of workers at
production and research facilities as well as for safeguarding the
surrounding communities and environment. When President Bill Clinton
appointed me, the Department 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 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

When the Occupational Safety and Health Administration (OSHA) was
established in 1971 to protect the health of workers 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 exposure limits for beryllium. Brush Wellman, the
nation's leading 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 later years of the
Clinton administration decided that although more research is always
desirable, the department had more than enough information to warrant
immediate implementation 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 technologically feasible.
This new standard, however, applies only to DOE workers; workers in
the private sector, who fall under OSHA's 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 2002 the agency implicitly accepted the industry's arguments
by issuing a call for additional data on the relation of beryllium
disease to, among other things, the size, surface area and number of
particles and the extent of skin contact. That is where matters stand

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 Prevention support this
conclusion. In 2002, however, statisticians from another product-
defense firm, Roth Associates in Rockville, Md., and the University of
Illinois published a reanalysis of a 10-year-old CDC study. By
changing some key parameters, the authors raised the estimates for the
background rate of lung cancer so that the elevation caused by
beryllium was no longer statistically significant. (This procedure is
rather easily accomplished, whereas the opposite--turning
insignificance into significance--is extremely difficult.) Brush
Weilman and NGK Metals, a producer of beryllium alloys, had funded the
research. The new analysis was published in Inhalation Toxicology, a
peer-reviewed journal--not one primarily focused on epidemiology but
peer-reviewed nonetheless--and the industry now touts its study as
evidence that everyone else is wrong.

This pattern is not unique to the beryllium 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 unwarranted. Out of the almost 3,000 chemicals
produced in large quantities (more than one million pounds annually),
OSHA enforces 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 unchanged. New science has had no impact
on them. I conclude that successive OSHA 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 become a big
business in itself. The product-defense firms have become experienced
and successful consultants in epidemiology, biostatistics and
toxicology. In fact, it is now unusual for the science behind any
proposed public health or environmental regulation not to be
challenged, no matter how powerful the evidence. Currently
representatives of indoor tanning salons are hard at work disparaging
the designation of ultraviolet radiation as a cause of skin cancer.
Furthermore, the denial of scientific evidence and the insistence on
an impossible certainty are not limited to business interests. For
instance, some zealous environmentalists remain adamantly opposed to
food irradiation--the use of gamma rays, x-rays or electron beams to
kill microbes in meats and produce--even though the benefits of the
practice greatly outweigh the risks.

PPA and Vioxx

THE POWER OF COMPANIES to influence and distort research 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
manufacturers--including Bayer, Sandoz (now part of Novartis), Wyeth
and GlaxoSmithKline--rejected the agency's concerns, 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 epidemiological 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 confirmed 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 firm based in Washington,
D.C., to attack the study and had their attorneys put the researchers
through grueling legal depositions. 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 amount 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 finally advised manufacturers to stop
marketing PPA in November 2000. The agency estimates that the chemical
caused between 200 and 500 strokes a year among 18- to 49-year-old

Or consider rofecoxib, more commonly known as Vioxx, the once popular
pain reliever made by Merck. Even before the 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 flags, but for
the most part the FDA ignored them. Then, in early 2000, the results
of a clinical trial showed that participants who took Vioxx for an
average of nine months had five 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 finding
to mean either that Vioxx increased heart attack risk by 400 percent
or that naproxen reduced the risk by an astounding 80 percent, making
it about three times as effective as aspirin in protecting the
cardiovascular system. Unsurprisingly, the company's researchers chose
the latter interpretation. But Merck abruptly turned about and took
Vioxx off the market 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
attacks--30 to 40 percent of which were probably fatal--in the five
years the drug was on the market.

Although the Wall Street Journal 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 percent. If they did, they should have
urged the government to pour it straight into the water supply. It
seems more likely that their allegiances were so tightly linked with
the products they worked on, as well as the financial health of their
employers, that their judgment became fatally impaired. And the FDA?
That agency has neither the legal authority nor the resources 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 scientific testimony to support their cases. Under the
precedents set by Daubert v. Merrell Dow Pharmaceuticals and two
related rulings, federal trial judges are now required to determine
whether the testimony is reliable and relevant. What began as a well-
intentioned effort to improve the quality of scientific evidence has
had troubling consequences: according to an analysis published in 2002
in the Journal of the American Medical Association, federal judges
have barred respected researchers from testifying in drug lawsuits
because their evidence--such 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."

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 shaping 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. Secretary of Health and Human Services Tommy Thompson
replaced prominent researchers with individuals more likely to side
with the lead industry. (One new member had testified on behalf of the
lead paint industry in a suit brought by the state of Rhode Islatid 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.

What is more, this administration has tried to facilitate and
institutionalize the corporate strategy of manufacturing uncertainty.
Its most significant tool is the Data Quality Act (DQA), a midnight
rider attached to a 2001 appropriations bill 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
beneficial; who wouldn't want to ensure the quality of government-
disseminated information? In practice, however, industry groups use
the DQA to slow or stop attempts at regulation by undercutting
scientific reports. The law gives corporations an established
procedure for killing or altering government documents with which they
do not agree. It has been used by groups bankrolled 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 Organization'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 information before
it becomes part of an official government document. To accomplish this
tantalizing goal, in August 2003 the Office of Management and Budget
(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 regulations 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 scientific

Enough was enough. In November 2003 the usually quiescent science
community finally rose up in protest at a meeting sponsored, at the
OMB's request, by the National Academy of Sciences. In the face of
this opposition--dozens of organizations fired off scathing letters to
the White House--the OMB retreated and implemented a less onerous
program that did not exclude the most qualified 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 government
scientists, agencies should be focusing more scrutiny on the data and
analyses provided by corporate scientists and product-defense firms.
And instead of allowing uncertainty to be an excuse for inaction,
regulators should return to first 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
definitively 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
Nagasaki. The model is not perfect, but the estimates are as accurate
as the available data and methods allow.

In that case, we did the right thing. Now it is time for industry to
do the right thing. We need a better balance between health and money.

DAVID MICHAELS is an epidemiologist who served as the U.S. Department
of Energy's assistant secretary for environment, safety and health
from 1998 to 2001. He is currently professor and associate chairman in
the department of environmental and occupational health at the George
Washington University School of Public Health and Health Services.

Copyright 2005 Scientific American Inc.