The recent news about the harmful effects of hormone replacement was
played in the media as a health story, but it is much more than that. In
fact, it may be the hot-flashiest corporate scandal to date: Let's call
If other corporate scandals have been about fudging figures, this one
is about fudging science--something that seems to have been surprisingly
easy to do. And such is the corporate culture that we have apparently
preferred to believe the drug companies rather than the women's health
advocates who have been lobbying for decades simply to get the
scientific evidence to back the companies' claims. The director of the
North American Menopause Society (NAMS), Dr. Wulf Utian, called the bad
news about hormones a bombshell, but it really isn't. Information has
been slowly accumulating about hormone replacement therapy's risks, even
as Wyeth and other manufacturers have been pushing their product as an
elixir for a widening group of symptoms. In recent years, this
potentially carcinogenic drug has been marketed with the nonchalance of
a vitamin pill: HRT advertising suggests that almost no woman over 50
couldn't benefit from it somehow.
Estron is the latest in a long line of scandals pitting women's health
against the interests of Big Pharma--scandals like the sale of faulty
Dalkon Shield contraceptives, which caused infertility, and medications
like DES, which caused severe illnesses in users and their children.
What all these cases have in common is that--like the manufacturers of
menopausal hormones--the drug companies, in their rush for profits,
insufficiently tested their wares before selling them to millions. What
these scandals suggest is that somewhere in the swampy landscape of
medical research funding, unhealthy relationships incubate between
medical practitioners and the drug-company reps who manage to dazzle
them with quasi science and quasi truths. The industry spends around $15
billion a year to promote its products--more than it spends to develop
them. Clearly, even those doctors who resisted the
luxury-cruise-lectures approach to sales found themselves suckered in.
The manipulation of HRT's scientific credentials began back in the
mid-1960s, when Wyeth paid gynecologist Dr. Robert Wilson to extol its
new wonder drug, estrogen replacement. In an evocatively named book,
Feminine Forever, Wilson declared that by replacing the estrogen
lost at menopause, women would remain attractive and easier to live
with. Over the decades since, Wyeth and other hormone manufacturers have
revised dosages and combinations to fit new medical revelations and
poured billions into sophisticated propaganda to get their message out.
The message is that menopause is not a natural life stage but a
disease--estrogen deficiency--and it will make you old. HRT is the cure,
and it will keep you young.
In recent years the manufacturers have claimed protective qualities for
HRT way beyond its original ambitions. First, it promised (and
delivered) relief from menopausal symptoms. Next came claims for
protection against heart disease in women already affected, and then in
healthy women. Then came its role as a treatment against osteoporosis,
which, manufacturers warned (falsely), becomes an instant risk at the
moment of menopause (it's a gradual risk over many years).
The truth is that the manufacturers didn't exactly know what HRT did or
didn't do, because they never ran a big, randomized national study
stringent enough to meet medical standards. For more than twenty years,
the companies used observational studies showing that women who took
hormones were healthier, but they didn't look at why: Was it that the
hormones themselves made women healthier, or that health-conscious women
were more likely to take hormones to begin with? There were many other
uncertainties. Yet calls to answer these questions, from women's health
groups and even from prominent politicians like Pat Schroeder and
Olympia Snowe, went unheeded.
For all the hype, there has been plenty of evidence, both scientific and
epidemiological, that estrogen, named a carcinogen by the FDA two years
ago, is not a wonder drug for everyone. Thirty percent of prescriptions
for estrogen remain unfilled, and the growing search for alternative
menopause products shows that increasing numbers of women are
uncomfortable with the prospect of a lifetime of swallowing synthesized
horse urine. And for all the spin, there has also been accumulating
evidence of serious side effects. As early as 1975 the FDA identified
links between estrogen and higher rates of uterine cancer. (Wyeth
responded by adding another product, progestin, to offset the risk.) In
1990 the Nurses Health Study reported that women on estrogen faced a 36
percent greater risk of breast cancer. That same year the FDA refused to
approve Premarin as a treatment to prevent heart disease, because the
company's evidence didn't convince them. The 2000 HERS study, actually
funded by Wyeth, found that hormone therapy increased risks in heart
disease patients in the first few years. (Wyeth countered that
long-term, it works.)
And people have been trying to warn us. As far back as the mid-1990s,
The Menopause Industry, by Australian reporter Sandra Coney,
presented heavily researched evidence of uterine bleeding, gallbladder
disease and increased cancer rates in hormone takers. In 1997 breast
cancer specialist Dr. Susan Love's Hormone Book returned to the
link between HRT and increased breast cancer risk and came under attack
for raising an alarm. Earlier this year Cindy Pearson, executive
director of the National Women's Health Network, published The Truth
About Hormone Replacement Therapy, outlining many other
discrepancies between hormone hype and science. The medical
establishment barely paid attention.
Finally, the scientific evidence that we have now, based on two large
randomized trials, is definitive, according to one of the study's
leaders, Dr. Deborah Grady. The trials have shown that not only does HRT
do more harm than good for women with existing heart disease, but it
doesn't protect healthy women either; in fact, during the trial it
increased incidence of heart attacks, breast cancer, strokes and blood
clots--enough to have caused the study to be abandoned three years
early. And yet belief in the hormone was so strong that researchers
feared it would be unethical to put women on placebos.
How is this possible? Dr. Utian of NAMS has admitted that many different
parties--from the drug companies to their paid researchers and
spokespeople to the prescribing gynecologists--have had a vested
interest in the success of hormone replacement, and for them, he told
the New York Times, the issue is about more than data. For them,
Utian said, truth is opinion. But that seems a risky precept for
physicians to work with. It sounds like something Arthur Andersen would
In June, the New England Journal of Medicine, one of the most respected medical journals, made a startling announcement.
At the fourteenth international AIDS conference, the gulf between the
United States and the rest of the world widened as US officials touted
policies that world health experts agree are ineffective strategies for
stemming the pandemic. Without stepped-up prevention efforts, 45 million
more people will become infected with HIV by 2010, according to the
Global HIV Prevention Working Group. Yet 29 million of these people
would never contract the virus if leaders ratcheted up preventive
strategies--most crucially teaching the use of condoms.
In European countries, including the Netherlands and Sweden, the
promotion of a variety of safe sex practices--abstinence, monogamy and
condom use--has reduced teen pregnancies and sexually transmitted
diseases. In Senegal and Uganda, it has cut the rate of new HIV
infections in half. In all these countries and in others, national
governments have supported such programs both rhetorically and
The White House, however, wants to expand programs enacted under the
Clinton Administration that tie federal funding of sex education to the
promotion of abstinence-only curriculums. While the vast majority of US
schools provide information about what HIV is and how it is transmitted,
less than half give students information about what condoms are or how
to use them, according to Centers for Disease Control surveys.
In a speech drowned out by angry protesters in Barcelona, US Secretary
of Health and Human Services Tommy Thompson touted the Administration's
$500 million drug initiative to prevent babies in Africa and the
Caribbean from becoming infected with HIV during birth or through
breastfeeding. He seemed confused when reporters later suggested that
preventing women, girls and their partners from becoming infected in the
first place might be a more productive strategy.
The evidence is clear: Campaigns that rely only on abstinence and drugs
to protect babies from AIDS won't slow the world pandemic. HIV
prevention does work when it is part of reproductive health programs
that recognize that sex is an integral component of human behavior.
Price-fixing fines behind them, the firms are close to achieving a
Big Pharma tries out First World drugs on unsuspecting Third World
The Pentagon's recent decision to limit anthrax vaccine shots to those
at high risk does not address the fundamental objection to the shots,
which is the lack of informed consent. The military maintains that it is
not required to seek informed consent for the vaccine because it is
currently approved by the Food and Drug Administration, and it continues
to court-martial personnel who refuse the vaccine. These servicemembers
contend that the vaccine is unsafe and that the military is not using it
in the prescribed manner.
The Pentagon announced its controversial plan to forcibly inoculate all
2.4 million troops against anthrax in 1997. Almost immediately, military
members began to protest, based in part on the revelation that
approximately 300,000 servicemembers had been given experimental drugs
without their knowledge in the Gulf War. Both during and after the Gulf
War, many military personnel experienced systemic medical problems,
which are often collectively termed Gulf War Syndrome. Seven years after
the Gulf War, the military finally admitted that it had used
experimental drugs on its personnel without their consent, and that
these drugs could be factors in the medical problems.
The FDA approved the current anthrax vaccine in 1970 primarily for
agricultural workers, but not for routine immunization on large
populations. Originally approved for a six-shot, eighteen-month
protocol, the vaccine is intended to treat cutaneous (through the skin)
anthrax, but has never been tested for inhalation anthrax, which is the
most deadly form and the most likely to occur in a combat situation.
Despite the military's assertions that very few adverse reactions have
been reported from the vaccine, the General Accounting Office found that
the Pentagon has been negligent in tracking such reactions. In fact,
many military personnel have reported adverse reactions. In 2000 the GAO
surveyed the National Guard and reserve forces given the vaccine, and 85
percent reported some reactions, with 23.8 percent reported to be
systemic. Additionally, the GAO reports that the long-term effects of
the anthrax vaccine have never been studied. In 1994 one of the Army's
top biological researchers wrote that "the current vaccine against
anthrax is unsatisfactory."
In 1996 the manufacturer BioPort submitted an application to the FDA to
amend the original anthrax vaccine license to include treatment of
inhalation anthrax as an approved use, as well as an approved reduction
in the vaccination schedule. FDA regulations specify that should an
organization desire a license change for a previously approved drug or a
modified dosing schedule, the drug essentially reverts to experimental
status. Due to a vaccine shortage, the military does not require that
personnel complete the six-shot protocol, and in some cases it has
prescribed that only two of the six required shots are necessary. So
under the current law, the military, in using the anthrax vaccine as a
prophylactic against inhalation anthrax, is basically using an
experimental drug on its own people without their consent.
In light of the Gulf War experimental drug abuses, the Pentagon's
circumvention of FDA regulations with anthrax vaccine is very
unsettling. Even after the anthrax scare post-9/11, we cannot simply
ignore the system of checks and balances for experimental drugs. In
volunteering for service, military members sacrifice much for their
country. Just as they are expected to conform to the rules of their
superiors, the Pentagon should be expected to obey the laws of the
Just-released inmates with infectious diseases need continuous treatment.
Speech to The Democratic National Committee--Western Caucus
Saturday, May 25, 2002
In the past two months I have talked with many people who have a keen
interest in whether the Senate will decide to ban therapeutic cloning.
At a conference at a Philadelphia hospital, a large number of people,
their bodies racked with tremors from Parkinson's disease, gathered to
hear me speak about the ethics of stem cell research. A few weeks
earlier I had spoken to another group, many of whom were breathing with
the assistance of oxygen tanks because they have a genetic disease,
Alpha-1 antitrypsin deficiency, that destroys their lungs and livers.
Earlier still I met with a group of parents whose children are paralyzed
as a result of spinal cord injuries.
At each meeting I told the audience there was a good chance that the
government would criminalize research that might find answers to their
ailments if it required using cloned human embryos, on the grounds that
research using such embryos is unethical. The audience members were
incredulous. And well they should have been. A bizarre alliance of
antiabortion religious zealots and technophobic neoconservatives along
with a smattering of scientifically befuddled antibiotech progressives
is pushing hard to insure that the Senate accords more moral concern to
cloned embryos in dishes than it does to kids who can't walk and
grandmothers who can't hold a fork or breathe.
Perhaps it should come as no surprise that George W. Bush and the House
of Representatives have already taken the position that any research
requiring the destruction of an embryo, cloned or otherwise, is wrong.
This view derives from the belief, held by many in the Republican camp,
that personhood begins at conception, that embryos are people and that
killing them to help other people is simply wrong. Although this view
about the moral status of embryos does not square with what is known
about them--science has shown that embryos require more than genes in
order to develop, that not all embryos have the capacity to become a
person and that not all conception begins a life--it at least has the
virtue of moral clarity.
But aside from those who see embryos as tiny people, such clarity of
moral vision is absent among cloning opponents. Consider the views of
Leon Kass, William Kristol, Charles Krauthammer and Francis Fukuyama.
Each says he opposes research involving the cloning of human embryos.
Each has been pushing furiously in the media and in policy circles to
make the case that nothing could be more morally heinous than harvesting
stem cells from such embryos. And each says that his repugnance at the
idea of cloning research has nothing to do with a religiously based view
of what an embryo is.
The core of the case against cloning for cures is that it involves the
creation, to quote the latest in a landslide of moral fulminations from
Krauthammer, "of a human embryo for the sole purpose of using it for its
parts...it will sanction the creation of an entire industry of embryo
manufacture whose explicit purpose is...dismemberment for research."
Sounds like a very grim business indeed--and some progressives, notably
Jeremy Rifkin and Norman Mailer, have sounded a similar alarm as they
have joined the anticloning crusade.
From the secular viewpoint, which Krauthammer and like-minded cloning
opponents claim to hold, there is no evidence for the position that
embryonic clones are persons or even potential persons. As a simple fact
of science, embryos that reside in dishes are going nowhere. The
potential to become anything requires a suitable environment. Talk of
"dismemberment," which implicitly confers moral status on embryos,
betrays the sort of faith-based thinking that Krauthammer says he wants
to eschew. Equally ill-informed is the notion that equivalent medical
benefits can be derived from research on adult stem cells; cloned
embryonic stem cells have unique properties that cannot be duplicated.
The idea that women could be transformed into commercial egg farms also
troubles Krauthammer, as well as some feminists and the Christian
Medical Association. The CMA estimates that to make embryonic stem-cell
cloning work, more than a billion eggs would have to be harvested. But
fortunately for those hoping for cures, the CMA is wrong: Needed now for
cloned embryonic stem-cell research are thousands of eggs, not billions.
While cloning people is a long shot, cloning embryos is not, and it
should be possible to get the research done either by paying women for
their eggs or asking those who suffer from a disease, or who know
someone they care about who has a disease, to donate them. Women are
already selling and donating eggs to others who are trying to have
babies. Women and men are also donating their kidneys, their bone marrow
and portions of their livers to help others, at far greater risk to
themselves than egg donation entails. And there is no reason that embryo
splitting, the technique used today in animals, could not provide the
requisite embryo and cloned stem-cell lines to treat all in need without
a big increase in voluntary egg donation from women.
In addition to conjuring up the frightening but unrealistic image of
women toiling in Dickensian embryo-cloning factories, those like
Krauthammer, who would leave so many senior citizens unable to move
their own bodies, offer two other moral thoughts. If we don't draw the
line at cloning for cures, there will soon enough be a clone moving into
your neighborhood; and besides, it is selfish and arrogant to seek to
alter our own genetic makeup to live longer.
The reality is that cloning has a terrible track record in making
embryos that can become fetuses, much less anything born alive. The most
recent review of cloning research shows an 85 percent failure rate in
getting cow embryos to develop into animals. And of those clones born
alive, a significant percentage, more than a third, have serious
life-threatening health problems. Cloned embryos have far less potential
than embryos created the old-fashioned way, or even frozen embryos, of
becoming anything except a ball of cells that can be tricked into
becoming other cells that can cure diseases. Where Krauthammer sees
cloned embryos as persons drawn and quartered for their organs, in
reality there exists merely a construct of a cell that has no potential
to become anything if it is kept safely in a dish and almost no
potential to develop even if it is put into a womb. Indeed, current work
on primate cloning has been so unproductive, which is to say none made
to date, that there is a growing sentiment in scientific circles that
human cloning for reproduction is impossible. The chance of anyone
cloning a full-fledged human is almost nil, but in any case there is no
reason that it cannot be stopped simply by banning the transfer of these
embryos into wombs.
But should we really be manipulating our genes to try to cure diseases
and live longer? Kass and Fukuyama, in various magazine pieces and
books, say no--that it is selfish and arrogant indulgence at its worst.
Humanity is not meant to play with its genes simply to live longer and
Now, it can be dangerous to try to change genes. One young man is dead
because of an experiment in gene therapy at my medical school. But the
idea that genes are the defining essence of who we are and therefore
cannot be touched or manipulated recalls the rantings of Gen. Jack D.
Ripper in Doctor Strangelove, who wanted to preserve the
integrity of his precious bodily fluids. There's nothing inherently
morally wrong with trying to engineer cells, genes and even cloned
embryos to repair diseases and terminal illnesses. Coming from those who
type on computers, wear glasses, inject themselves with insulin, have
had an organ transplant, who walk with crutches or artificial joints or
who have used in vitro fertilization or neonatal intensive care to
create their children, talk of the inviolate essence of human nature and
repugnance at the "manufactured" posthuman is at best disingenuous.
The debate over human cloning and stem cell research has not been one of
this nation's finest moral hours. Pseudoscience, ideology and plain
fearmongering have been much in evidence. If the discussions were merely
academic, this would be merely unfortunate. They are not. The flimsy
case against cloning for cures is being brought to the White House, the
Senate and the American people as if the opponents hold the moral high
ground. They don't. The sick and the dying do. The Senate must keep its
moral priorities firmly in mind as the vote on banning therapeutic
cloning draws close.