Statements
and Speeches
Food
and Drug Law Institute
April 1, 2003
Good morning. I'm pleased to be here. World events right now so
overshadow other issues that it is tempting to focus on nothing
else. But while terrorism and Saddam Hussein may pose serious threats
to the health and safety of the American people, there are others
that cannot be ignored. The epidemic of Severe Acute Respiratory
Syndrome spreads with each passing day. And this year, preventable
or treatable illness will needlessly kill hundreds of thousands
of Americans.
In the coming
months and years, the FDA will be front and center in dealing with
the most pressing health challenges facing the United States. Today,
I would like to make the case that success depends upon how well
the agency performs its key role - supporting medical progress and
public health through science-based regulation. I will argue that
failure lurks where politics and ideology are allowed to skew the
agency's mission.
In the field
of military power, none of us would question that the Defense Department
should select military equipment based on the best available science.
There is no room for asking which missile manufacturer has the right
religious views, or for even suggesting that troops in harm's way
rely on equipment that has not been rigorously tested.
Yet, in the
field of public health, and increasingly in the field of food and
drug regulation, some are quite willing to look to turn away from
science and towards politics, religion and ideology for answers.
They are willing to expose the public to health-related products
on the basis of preliminary data and unproven theories. Unfortunately,
some of those people are decision-makers in this Administration.
Across cabinet-level
Departments, expert appointments to scientific advisory boards and
peer review panels are going to individuals with specific ideological
viewpoints rather than scientific credentials. Scientific information
that does not serve the Administration's political agenda has been
suppressed or altered. Science-based regulation of significant health
and environmental risks, from arsenic levels to industrial pollution,
has been rolled back.
Within HHS,
for example this Administration has altered CDC web sites on contraception
and AIDS prevention, erasing key facts about condom use that could
save lives. At the National Cancer Institute, officials changed
a web page to read that abortion might lead to breast cancer, despite
overwhelming evidence to the contrary. After Congressional pressure
and a meeting of 100 experts, the NCI now acknowledges that experts
have concluded there is no link between breast cancer and abortion,
yet the misleading webpage remains up.
On lead poisoning,
this Administration replaced a leading academic expert on a key
advisory committee with a paid lead industry consultant who believes
a lead level of 70 does not produce long-term effects on learning
and behavior. This is a position that was universally rejected by
the scientific community -- thirty years ago.
The FDA has
been anything but immune from the Administration's willingness to
sacrifice science for political ends.
As we approach
the 100th anniversary of the agency, we must remember that the history
of food and drug regulation has shown us over and over again that
our nation's food and drug industries thrive only when there is
a strong FDA protecting the public from unsafe and ineffective products.
When consumers are exposed to scams, unjustified claims, or needlessly
dangerous products, consumer confidence evaporates. Over the long
term, patients and industry either suffer or advance together.
This idea is
so obvious it is remarkable how often it appears to be ignored at
today's FDA. I not going to sugar coat my message: Over the last
two years, the FDA has embarked on a path that poses grave dangers
not only to American consumers but ultimately to the companies that
manufacture them and to scientific progress itself.
In December,
this Administration appointed to the FDA advisory committee that
oversees reproductive health drugs a physician whose qualifications
for the position appear to have more to do with his opposition to
abortion and his religious views than to his academic credentials.
This is a doctor who apparently counseled women to read scripture
as a treatment for PMS and who refused to prescribe contraceptives
for unmarried women.
Some may think that one spot on one advisory committee won't make
much of a difference. But I would argue that this appointment is
a very ominous sign for an agency that is dedicated to science.
Once we accept
the idea that ideological views can substitute for objective, scientific
analysis, the review of health-related products has the potential
to become a political process rather than a scientific one. I don't
believe that any of us want that to happen.
It is a small
step from appointing people based on ideology, to manipulating scientific
information to fit an ideological preference. In January, an FDA
press release claimed to describe the results of a scientific survey
of physicians on direct-to-consumer advertising. To read the press
release, one might have concluded that physicians thought DTC advertising
was the greatest advance in patient care since padded examining
tables.
In fact, it
is quite clear that FDA significantly slanted the results of the
survey in order to make a case for greater DTC advertising.
For example,
the FDA Talk Paper states:
"According
to the survey, one effect of DTC ads was to help educate patients
about their health problems..."
In fact, the
survey data showed that only ten percent of the physicians surveyed
felt the patient was better educated or informed due to DTC advertising.
By comparison, 75% of the physicians said the DTC advertisements
caused patients to think a drug worked better than it did. And 60%
of their patients understood only a little or had no understanding
of possible risks and negative effects of an advertised drug.
Ignoring or
minimizing these and other inconvenient facts revealed in the survey,
the talk paper concluded,
"These
new results confirm FDA's current understanding . . . Ads can and
do help increase patient awareness about the availability of effective
treatments for their health problems."
This conclusion
was an ideological one, not a scientific one.
A fair reading of the survey results is that physicians had both
positive and negative views about DTC ads, in about equal measure.
But FDA did not provide a fair reading of the survey. Instead, it
published something very close to a puff piece for DTC advertising.
Again, you may
question whether distorting the results of a survey on DTC advertising
really matters. It does. It shows a disdain for scientific truth
that can infect far more important decisions.
Public health
agencies like the FDA run tremendous risks when they play fast and
loose with scientific data. They run those risks with their own
credibility, with the credibility of the products they regulate,
and ultimately with the lives of the American people.
Yes, there are
lives very much at risk when ideology trumps science at FDA. I encourage
everyone here to read Philip Hilts book on the history of the FDA
entitled Protecting America's Health. This book tells the story
of a steady stream of tragedies that shaped the agency and the people
who have run it.
Today, I am
very concerned that an agency that does not understand this history
will be condemned to repeat it. I am referring to this Administration's
approach to regulating advertising claims, arguably the core function
of FDA for the past century.
The Federal
Food, Drug, and Cosmetic Act doesn't permit companies to advertise
unapproved health claims for foods or drugs. The Act presumes that
promoting unapproved health claims is inherently misleading. Because
preliminary evidence is often misleading. And because neither patients
nor physicians are in a position to evaluate the quality of the
data supporting unapproved claims.
This Administration
has signaled an interest in loosening the rules on promotion of
foods and drugs, particularly on advertising of unapproved uses
of approved drugs. In fact it has already substantially lowered
the level of evidence needed to make a health claim about a food.
The ideological
principle behind lifting the restrictions on advertising of foods
and drugs is that commercial speech should not be restricted any
more than political speech.
Underlying that principle is the view that more information is better
than less, and that even if the information is based on preliminary
data or unproven theories, no one is harmed as long as the information
is not false or misleading. In fact, according to the FDA, waiting
for proof of safety and effectiveness could itself be harmful by
depriving people of useful information that could enhance their
health.
(I will let
someone else comment on the irony that this is the same Administration
that is energetically suppressing scientific evidence on the effectiveness
of condoms.)
According to
the FDA, lifting advertising restrictions would be a step forward.
But what the FDA is really contemplating is turning back the clock
several decades. And history has already fully documented the harm
to American lives and health when you permit companies to advertise
health claims without demonstrating their effectiveness.
Before 1962,
when drug companies were first required to demonstrate the effectiveness
of their products before approval, they were subject to a regime
much like that apparently favored by the Administration. Industry
could make unapproved effectiveness claims about their products,
as long as the claims were truthful and not misleading.
Congress held
several years of hearings on the drug industry in the late 1950s
and early 1960s. The hearings detailed a marketplace rife with drugs
that were promoted on the strength of preliminary evidence or nice
theories, but that were ultimately shown to be ineffective and sometimes
dangerous for their claimed uses. The hearings revealed that:
" Drugs were being promoted for indications far beyond any
responsible evidence of their effectiveness and even for indications
for which they were known to be ineffective. This was borne out
by a review of marketed drugs in 1962, which revealed that one-third
of all drugs on the market were ineffective for any use, and that
a much higher percentage of secondary indications lacked evidence
of effectiveness;
The hearings
also found that:
" In the
absence of an effectiveness requirement, manufacturers rarely carried
out adequate effectiveness tests;
And that:
" Truthful information was impossible to separate from misleading
information because promotional material distorted the available
evidence in ways that made harried physicians believe they had adequate
information to make prescribing decisions; and
The record also
showed that:
" The use
of ineffective drugs subjected patients to severe harm. Patients
suffered serious side effects without any corresponding benefit.
And the use of ineffective drugs delayed or prevented them from
getting effective treatment for serious and life-threatening conditions.
Let me give
you an example of the harm caused by the marketing of a drug based
on an unproven theory rather than on dispositive scientific studies.
The drug DES, a synthetic estrogen, was promoted to millions of
healthy women for preventing miscarriage in the 1950s and 60s, on
the strength of the theory that miscarriage was caused by inadequate
estrogen production.
Twenty years
later, it was learned that DES was responsible for thousands of
cases of unusual cancers and serious reproductive abnormalities
in the children of women given DES. Perhaps the greatest tragedy
of DES is that none of the harm to those young people was necessary:
scientific studies ultimately disproved the theory on which DES
was marketed and showed that DES was ineffective for preventing
miscarriages.
But, you say,
the FDA could stop claims that were false or misleading. In reality,
the hearings showed that enforcement actions against misleading
claims were virtually futile because the FDA couldn't begin to police
them all. When the FDA or FTC did bring an action, it took months
and more often years, while the products continued to be promoted
and to cause harm.
Let me quote
then Secretary of Health, Education, and Welfare, Abraham Ribicoff,
on the adequacy of the regulatory regime he oversaw, where the burden
was on the FDA to prove that promotional claims were false or misleading:
"If claims
for effectiveness are made which the FDA believes are groundless,
a proceeding must then be brought to take the drug off the market
as a misbranded product. . . . And throughout the period of time
it takes for the FDA to prepare its case and secure relief in the
courts, the manufacturer will have foisted his product upon an unsuspecting
public.
" . .
. . where public health is involved it is intolerable to permit
the marketing of worthless products under the rules of a cat-and-mouse
game where a manufacturer can fool the public until the Food and
Drug Administration finally catches up with him."
Forty years
after DES, why would we possibly want to return to this cat and
mouse game? Two recent cases illustrate the folly of even considering
this idea.
Hormone replacement therapy, or HRT, was approved for treatment
of the symptoms of menopause and prevention of osteoporosis. But
for years HRT was widely believed, on the basis of observational
studies, to protect women against heart disease. The first prospective,
well-controlled trial, however, was stopped when it revealed that
HRT not only failed to protect women against heart disease, it increased
their risk of heart attack and stroke. Most of the medical community
was stunned.
In January,
a large safety study of the asthma drug Serevent was halted when
it was discovered that use of the drug was associated with an increased
risk of life-threatening asthma episodes and deaths, especially
in African-Americans. Serevent is approved for use only when taken
with other asthma medications. The increased risk of death was particularly
evident in patients taking the drug by itself, an unapproved use.
What makes
these cases particularly striking is that the manufacturers of both
HRT and Serevent had previously been stopped by FDA from promoting
their products for the unapproved uses in question.
Do I think
that either of these companies was deliberately promoting its product
for a dangerous use? No. In all likelihood, the companies were suffering
from the same problem that faces anyone trying to understand the
uses of a drug based on preliminary evidence or appealing theories:
they were misled because they did not have access to adequate scientific
data.
Let's ask what
would have happened in a legal system where the burden was on FDA
to prove that claims for these unapproved uses of HRT and Serverent
were false or misleading. Before the definitive studies were done,
could FDA have proven that the companies' claims were false or misleading?
No again.
In other words,
until adequate scientific data were available, the company couldn't
know whether its product worked as advertised, and FDA couldn't
have proved that it didn't. So under a system where FDA must prove
a claim to be false or misleading, these drugs could have been widely
promoted for their unapproved uses. We can count ourselves lucky
that we don't live under such a system.
Permitting companies to promote unapproved uses on the strength
of preliminary evidence or unproven theories may satisfy an ideological
preference for unrestricted commercial speech. It does not make
good public health sense. And it is not consistent with the role
Congress has assigned FDA. HRT, Serverent, and DES all show that
we can't know whether it is wise to broadly promote a product until
we have adequate scientific data to judge its safety and its effectiveness.
At the beginning of my comments, I drew an analogy between our military
and the public health.
I think we can
all agree that it would be terrible if we selected the technologies
and weapons relied upon by our troops based on preliminary data
suggesting the weapons might work, or worse, on the ideological
leanings of their manufacturers. Why do we insist that military
technology be proven to work? Because the lives of American soldiers
depend upon their equipment working, and the lives of the American
people depend upon our military effectively protecting them.
In the field
of public health, however, the Administration has begun to take
a less scientific approach. I believe that this approach is entirely
unacceptable, for the same reason that it would be unacceptable
in the military. Because human lives depend upon our public health
system as well.
I don't intend
to stand by idly and let this happen, and neither should you. I'm
sure that as Americans who care about their country, all of you
want our health policy to be as effective as possible.
I will be critical
of FDA's actions where they appear to undermine science and the
public health, as I have been today. But I also will stand up for
products manufactured by the industries represented here today in
the face of unfair criticism. For example, I have consistently fought
to make sure discussion of the safety of vaccines is informed by
science, not speculation about, for example, their possible relationship
to autism. I am committed to preventing these vital weapons against
disease from being undermined by unsubstantiated and unscientific
allegations.
We must all
continue to insist that vaccines and other products be judged on
scientific evidence, not on unproven theories.
I know that
those in the food and drug industry who are here today share this
interest in avoiding unscientific attacks. And so I challenge you,
just as you ask the public not to judge your products on poor science,
ask the FDA to rigorously apply science to the manufacture and marketing
of your products.
Do not be seduced
by the promise of a bigger market in the short term at the cost
of shaking the foundation of consumer confidence in food and drugs.
It will be a bad day for the food and drug industry if the public
comes to see our health policy as based on political interests rather
than science. Because on that day, the public will come to distrust
government decisions approving products for sale.
In this crucial
arena, the interests of industry and the public overlap. And I hope
that you will join me in working for both of them and fighting this
trend towards the politicization of health science.
|