FDA vs. Women’s Health, Again

Feminists in the United States
waged a decade-long battle against right wing activists to bring an important
medical technology to the United States only to experience years of foot
dragging from the Clinton administration which recently announced it still
won’t allow women access to a drug that has been available in Europe for
12 years.

The drug, of course, is RU-486
and induces an abortion 95.5 percent of the time when taken within the
first 49 days of pregnancy. Originally developed by Hoechst AG, the drug
first went on sale in France in 1988.

Unfortunately anti-abortion
activists actively campaigned to keep the drug from being available in
the United States. Promising to retaliate against Hoechst AG if the drug
were sold in the United States, the drug company refused to allow Roussel
Uclaf — which held RU-486’s marketing rights for the United States —
to market the drug here.

The anti-abortion groups were
aided by Congress and the Bush administration. In 1989 the U.S. Food and
Drug Administration banned the import of RU-486 for personal use. U.S.
Customs seized a prescription of RU-486 from an American citizen brought
to the United States after a trip to Europe and the Supreme Court refused
to hear the pregnant woman’s appeal of the seizure, allowing the FDA ban
to stand.

But feminists thought that
would all change with the election of Bill Clinton in 1992. In an effort
to court feminist voters, candidate Clinton pledged his support for bringing
RU-486 to this country and after the election the FDA announced that it
could review and approve RU-486 in as little as six months. FDA Commissioner
David Kessler wrote to Roussel Uclaf and encouraged the company to submit
the drug for approval.

Unfortunately Hoechst AG and
Roussel Uclaf still were resistant to selling the drug in the United States,
but agreed to transfer the marketing rights to the nonprofit Population
Council. Finally, on May 16, 1994 the Population Council was granted the
U.S. patent rights to RU-486 and clinical trials began in October 1994.
And almost six years later the drug is still not available in the
United States (so much for that six month speedy approval the Clinton
FDA promised.)

All of the studies conducted
so far indicate the drug is safe and effective, yet the FDA still refuses
to grant it final approval. Just last week, the FDA announced that it
still is not ready to approve the drug, saying that it had concerns about
the manufacturing and labeling of the drug, which is pretty much the same
thing the FDA said in a 1996 letter.

Planned Parenthood spokeswoman
hit the nail on the head when she said, “We think it’s appalling that
for 10 years the world’s most industrialized nation has not had access
to this drug that would benefit women.”

This is a classic example of
the idiocy of the FDA. Although in the 1950s or 1960s, U.S. drug approval
processes might have been said to be superior to Europe’s, today the techniques
for distinguishing between safe and unsafe medications are well known
and practiced by all Western industrial nations. A much better policy
would be to allow any drug approved for sale in Europe to be sold in the
United States with a warning that the drug has been reviewed by European
regulatory agencies but not the U.S. FDA.

Why not let women choose for
themselves what to do with their bodies? Or are we to assume that the
same woman able to decide whether or not to abort a fetus is simply incapable
of making a decision about whether or not to take a drug that has been
approved an in use in Europe for more than a decade?

References:

French
abortion pill falls short of FDA requirements
. Fox News, February
21, 2000.

The Fight To
Make RU-486 Available To U.S. Women
. From The Feminist Majority Foundation.

FDA vs. Women’s Health Again

Feminists in the United States
waged a decade-long battle against right wing activists to bring an important
medical technology to the United States only to experience years of foot
dragging from the Clinton administration which recently announced it still
won’t allow women access to a drug that has been available in Europe for
12 years.

The drug, of course, is RU-486
and induces an abortion 95.5 percent of the time when taken within the
first 49 days of pregnancy. Originally developed by Hoechst AG, the drug
first went on sale in France in 1988.

Unfortunately anti-abortion
activists actively campaigned to keep the drug from being available in
the United States. Promising to retaliate against Hoechst AG if the drug
were sold in the United States, the drug company refused to allow Roussel
Uclaf — which held RU-486’s marketing rights for the United States —
to market the drug here.

The anti-abortion groups were
aided by Congress and the Bush administration. In 1989 the U.S. Food and
Drug Administration banned the import of RU-486 for personal use. U.S.
Customs seized a prescription of RU-486 from an American citizen brought
to the United States after a trip to Europe and the Supreme Court refused
to hear the pregnant woman’s appeal of the seizure, allowing the FDA ban
to stand.

But feminists thought that
would all change with the election of Bill Clinton in 1992. In an effort
to court feminist voters, candidate Clinton pledged his support for bringing
RU-486 to this country and after the election the FDA announced that it
could review and approve RU-486 in as little as six months. FDA Commissioner
David Kessler wrote to Roussel Uclaf and encouraged the company to submit
the drug for approval.

Unfortunately Hoechst AG and
Roussel Uclaf still were resistant to selling the drug in the United States,
but agreed to transfer the marketing rights to the nonprofit Population
Council. Finally, on May 16, 1994 the Population Council was granted the
U.S. patent rights to RU-486 and clinical trials began in October 1994.
And almost six years later the drug is still not available in the
United States (so much for that six month speedy approval the Clinton
FDA promised.)

All of the studies conducted
so far indicate the drug is safe and effective, yet the FDA still refuses
to grant it final approval. Just last week, the FDA announced that it
still is not ready to approve the drug, saying that it had concerns about
the manufacturing and labeling of the drug, which is pretty much the same
thing the FDA said in a 1996 letter.

Planned Parenthood spokeswoman
hit the nail on the head when she said, “We think it’s appalling that
for 10 years the world’s most industrialized nation has not had access
to this drug that would benefit women.”

This is a classic example of
the idiocy of the FDA. Although in the 1950s or 1960s, U.S. drug approval
processes might have been said to be superior to Europe’s, today the techniques
for distinguishing between safe and unsafe medications are well known
and practiced by all Western industrial nations. A much better policy
would be to allow any drug approved for sale in Europe to be sold in the
United States with a warning that the drug has been reviewed by European
regulatory agencies but not the U.S. FDA.

Why not let women choose for
themselves what to do with their bodies? Or are we to assume that the
same woman able to decide whether or not to abort a fetus is simply incapable
of making a decision about whether or not to take a drug that has been
approved an in use in Europe for more than a decade?

French
abortion pill falls short of FDA requirements
. Fox News, February
21, 2000.

The Fight To
Make RU-486 Available To U.S. Women
. From The Feminist Majority Foundation.

Animal rights activist accused of suborning perjury, case thrown out

    Wisconsin animal rights activist
Cindy Schultz did not appreciate being mentioned as a possible suspect
in a high profile dognapping case in Milwaukee and sued the Milwaukee
Journal Sentinel, local radio host Charles Sykes, and his employer the
Journal Broadcast Group.

    Unfortunately for her, a circuit
judge hearing the case summarily dismissed all charges after Schultz apparently
committed perjury and attempted to suborn the perjury of another witness.

    Schultz heads an animal rights
group called the Animal Lobby and is a political operative who worked
on the campaigns of a variety of state and national political candidates.

    Schultz was initially charged
in the theft of two dogs, but the charges were later dismissed; Schultz
denies she was involved in the theft. Before the libel trial a former
friend of Schultz’s, Clary Engel, came forward to claim that Schultz had
asked him to lie about where she was on the day the dogs were stolen and
that Schultz had once asked him to steal the dogs.

    Schultz denied that she asked
Engel to lie, but unfortunately for her Engel still had copies of typewritten
“scripts” that Schultz had written illustrating how Engel should answer
questions at trial. Schultz lamely argued that although she had indeed
typed up scripts for Schultz, she wasn’t suborning perjury because everything
in the scripts was true. This despite the fact that one of the typed scripts
instructed Engel to testify that he had never discussed his testimony
with Schultz.

    In dismissing the civil suit,
Milwaukee County Circuit Judge Francis Wasielewski said Schultz had tried
to commit a “fraud on the court.”

[Schultz] . . . gave this court the impression of evasiveness
on several occasions. . . . Sometimes she avoided questions posed by answering
other questions. . . . She seemed to duck questions with feigned confusion.
Overall, she didn’t give this court the impression of being forthcoming
in testifying and of being someone who wanted to aid in a search for the
truth.

    Schultz’s lawsuit, aimed she
said at recovering damages for her ruined reputation, could end up costing
her even more. Because of the alleged perjury, the defense attorneys are
now planning a motion to force Schultz to pay all of the defendant’s legal
fees, which a defense lawyer described as being “substantial.”

Reference:

Animal
rights activist’s suit tossed out
. Jessica McBride, Milwaukee Journal
Sentinel, January 21, 2000.

Stem cell therapy reverses diabetes in mice

For years now, one of the tantalizing
possibilites for stem cell researchers has been using the technique to
provide a treatment for diabetes. That promise took a large step forward
in February when researchers announced they had managed to reverse diabetes
in mice using stem cells.

Stem cells are “master” cells
that direct the creation of other cells in the body. In this case researchers
isolated stem cells from the pancreases of mice, and transferred them
into diabetic mice.

The mice suffered from a condition
similar to Type-I diabetes (also called juvenile diabetes) in humans.
In this form of diabetes, which afflicts about 1.6 million Americans,
the body develops an immune response to islet cells that produce insulin
and attack the cells, interfering with the body’s ability to control levels
of blood sugar. Currently Type-I diabetes is usually treated with insulin
injections (another technology developed thanks to extensive animal experimentation).

When the pancreas stem cells
were injected in the mice, they spurred the creation of islets which produce
insulin in the mice, reversing their diabetic condition.

The next step will be seeing
if the phenomenon can be repeated in human beings, and the researchers
are confident that this will be replicable. “In preliminary experiments
it appears that we can take human pancreatic duct cells and show that
they can differentiate into islet cells as well,” said Dr. Desmond Schatz,
a diabetes expert who worked on the stem cell research at the University
of Florida in Gainesville.

Reference:

U.S. team reversed mouse diabetes with stem cells. Reuters, February
28, 2000.

Researchers advance understanding of rotavirus

    Medical researchers studying
rotavirus in mice recently reported the disease appears to act by stimulating
nerves in the intestines. Rotavirus is the main cause of stomach problems
and diarrhea in infants. Worldwide the disease kills more than 600,000
infants and children annually, mostly in the developing world.

    The researchers infected baby
mice with the rotavirus and then treated the mice with lidocaine, which
numbs the nerves. The lidocaine treatment cut in half the number of diarrhea
infections in the mice suggesting that the virus indeed acts by stimulating
the nerves (one hypothesis is that the rotavirus activates the nervous
system in the intestinal wall resulting in the expression of intestinal
fluid and electrolytes, resulting in the diarrhea).

    Although this finding is unlikely
in itself to lead to any new treatment for rotavirus, it does provide
an important advance — if verified by further studies, this confirms
that all the major causes of acute diarrhea in infants and children, including
cholera and E. coli, work by stimulating the nerves in the intestines
and might be treatable by a single therapy that numbs those nerves.

Reference:

Baby killer disease ‘explained’. The BBC, January 22, 2000.

China’s Religious Dilemma

In mid-February China issued
an analysis of its own human rights record that was a classic study in
Communist follies. The same day the Chinese government issued the report
— which claimed among other things that Chinese citizens enjoy a level
of democracy and freedom unprecedented in world history — the Chinese
government sentenced pro-democracy activist Liu Shizu to six years in
jail for trying to set up branches of the outlawed China Democracy Party.
Apparently the constitutional guarantees of the right to free association
and free speech, which the human rights report extolled, have yet to be
communicated to China’s judiciary.

China today faces much the
same problem that former Soviet leader Mikhail Gorbachev faced. Freedom
works — open and democratic societies are flourishing. Dictatorships
also work to a large extent — North Korea is proof that if a government
is willing to take the necessary measures, dictatorships can survive even
the most sever privation.

But the middle road does not
work. Trying to make people half free inevitably leads to demands for
further freedom from the populace alongside demands for more curtailing
of freedom from elites (especially military elites). Gorbachev reached
a point where he had only two options — go forward with freedom or turn
back to hardline repression. He chose the former and the rest is history.
China’s leaders have put themselves on the same collision course.

China has seen its economy
take off with a loosening of official restrictions, but at the same time
its leaders have been shocked by the way individuals have used their newfound
freedom. One of the most disturbing trends has been a rise in religious
involvement by many Chinese, including significant numbers of government
officials.

The most publicized such movement
is the Falun Gong. Not quite a religion, Falun Gong combines mediation,
slow-motion exercises, and an eclectic set of views drawn from Buddhism,
Taoism and Falun Fong founder Li Hongzhi.

The group became very popular
in the late 1990s with even the Chinese government conceding it has at
least 2 million members and Falun Gong officials claiming up to 100 million
members.

Whatever the merits of its
religious message, the Falun Gong certainly knows how to flex its muscle.
Complaining of harassment from the state and media, it organized a 10,000-person
protest in Tianamen Square in April of 1999 in which protesters surrounded
the main Communist Party headquarters. In July the Chinese government
responded by banning Falun Gong and beginning a round-up of its most important
members. According to the Hong Kong-based Information Center of Human
Rights and Democratic Movement in China, more than 5,000 Falun Gong members
have been sent to labor camps without trial and another 300 have been
sentenced to prison terms of up to 18 years.

The week before China published
its report praising its human rights record, the government arrested 500
Falun Gong adherents in Beijing just prior to the start of the Lunar New
Year.

What certainly makes Chinese
leaders fearful is the emergence of any movement that is not completely
dependent on the Communist Party. Since the Communists came to power in
China they have paid special attention to religious institutions, generally
permitting such institutions provided they are subservient to the state.

This is what motivates much
of China’s interaction with Tibetan Buddhism for example. China suffered
an embarrassing loss in January when it was revealed that the 14-year-old
Karampa fled Tibet and made a harrowing 8 day trek to India. The Karampa
is the third most important figure in Tibetan Buddhism.

Tibetan Buddhists believe that
their highest religious leaders are reincarnated and when one dies his
successor is identified by divination. The Chinese government has intervened
in this process and attempted to force Tibetans Buddhists to select leaders
it thinks it can groom into pro-Chinese religious figures, thereby keeping
Tibetan Buddhism under state control. So far, China has had little success
doing so in Tibet.

Its success in controlling
Roman Catholicism is also modest. In 1951 China forced the Catholic Church
under the state and only recognizes Christians who belong to denominations
approved by the state. Still, China has never been able to completely
get rid of a parallel independent structure maintained by Catholics who
continue to have allegiance to the Vatican.

In between suppressing the
Falun Gong and seeing the Karmapa slip through its fingers, the Chinese
government sent about 150 police to arrest Archbishop John Yang Shudao
in mid-February. Shudao has spent much of his life in and out of Chinese
prisons for, among other things, refusing to denounce the Pope and has
long been part of the independent Catholic Church in China that the government
has tried to destroy.

Unfortunately China is at odds
with its own policies. The openness and relaxation of state repression
that fueled its economic growth in the 1980s and 1990s is precisely what
has led to the explosion in religious expression in China. The government
will find it impossible to suppress the one without also suppressing the
other.

References:

China hails human rights leap forward. The BBC, February 17, 2000.

Communist China losing ground in battle with religion. The Associated
Press, January 17, 2000.

China jails Falun Gong member for 9 years. Reuters, February 14, 2000.

Arrest of bishop seen as latest signs of crackdown in China. The Associated
Press, February 15, 2000.

Report: 2,000 members of banned sect detained in past 5 days. The Associated
Press, February 10, 2000.

China combats ‘hostile forces’ wielding religion. The Associated Press,
January 11, 2000.

Another Chinese spiritual group ‘faces suppression’. The BBC, January
19, 2000.

China’s airbrush aimed at history. The Christian Science Monitor, January
28, 2000.

China moves to control Internet. The BBC, January 26, 2000.