I was calling to let you know the results of the pregnancy test, and unfortunately it
did come back negative for pregnancy.
For infertile couples like Don and Nancy, news like this begins a long road of disappointment
and despair.
But today, remarkable medical breakthroughs offer new hope to people who can't make babies.
Contraception in the 1960s separated sex from procreation.
Now we're separating procreation from sex, and that has a variety of implications.
Embryos can be produced in the laboratory.
They can be frozen, stored, and transferred from one woman to another.
But what price should we pay for these advances?
Why spend a lot of scarce resources on trying to create babies when there seem to be lots
of them around that might be placed with people who want them?
With the power to create human life, the new reproductive technologies now challenge some
of our most deeply held beliefs.
Are we ready for a future of high-tech babies?
Next on NOVA.
Major funding for NOVA is provided by this station and other public television stations
nationwide.
Additional funding was provided by the Johnson & Johnson family of companies, supplying health
care products worldwide.
And by Allied Signal, a technology leader in aerospace, electronics, automotive products,
and engineered material.
Oh my goodness.
In December 1981, a daughter was born to Judy and Roger Carr.
For a couple who'd been trying to have a child for four years, Elizabeth was a miracle.
For the rest of the country, she was a triumph of technology, America's first test tube
baby.
The doctors responsible for her birth were Howard and Georgiana Jones.
The technique, pioneered in England, is called in vitro fertilization.
It means that an egg is fertilized outside the mother's body in a glass laboratory dish
in vitro.
In 1985, Elizabeth Carr, here in the arms of Howard Jones, joins 55 other babies conceived
at his clinic in Virginia.
There are now almost 150 in vitro programs in the country, and somewhere in the world
a test tube baby is born every day.
One of the basic human drives is the need to reproduce ourselves, but one out of seven
couples is infertile.
Now, in vitro fertilization, or IVF, offers many of them an increasingly complicated array
of techniques for making babies.
If a woman has blocked fallopian tubes where conception normally occurs, her egg can be
removed surgically and fertilized with her husband's sperm in vitro.
In three days, the growing embryo is placed in her womb, or it can be stored in a freezer
for later use.
If a woman's womb cannot sustain a pregnancy, her embryo can be placed in a surrogate who
will carry the baby and return it to her at birth.
In another case, if the woman has no eggs, she can use a donated egg and combine it with
her husband's sperm in vitro to create an embryo that she will carry herself.
Using IVF, a child can have five parents, the couple who donates the embryo, the surrogate
who carries it, and the couple who raises the child.
But as the options multiply, so do the controversies.
I think the reason it's frightening is that it challenges something that we've always
held as a long-term, stabilizing belief in our society, in every society.
Mothers are biologically related to their children.
And when you break the tie between mothering, gestational mothering, and the identity of
the child as belonging to that mother, that's revolutionary.
There are people ready to run away with this technology and be first in doing some rather
strange things.
Furthermore, it can get very closely tied up with commercialization, with, I think,
some incompetence that can be unjust.
In the media, we have the pictures of the happy mothers with the smiling babies when
a birth actually occurs.
But in fact, they don't understand that most women go away from these programs without
a baby.
The vast majority do that.
At a news conference today at Good Samaritan Hospital, Dr. Richard Mars announced the first
two pregnancies in this country using frozen embryos.
This is a major breakthrough for Dr. Richard Mars, a prominent in vitro specialist.
Now when a woman fails to get pregnant from IVF, she can try again with embryos of her
own that she's frozen and stored.
So far, the technology has had few successes.
Zoe Leyland, born in Australia in 1984, was the first of only 10 babies in the world born
from a frozen embryo.
Embryo freezing is an experimental process.
It's not something that's ready to be used in a widespread fashion.
And we have to learn more about it.
In any first approach at a new technology, there's going to be things that are done
that are not the right way because we don't know what the right way is.
Otherwise, we wouldn't be experimenting.
And the patients understand that, and we understand that.
Nancy and Don Rubenstein have been Dr. Mars patients for five years.
They've stored six embryos in his freezer.
Now that he's achieved a pregnancy using frozen embryos, they've decided to have their thought
and put into Nancy's uterus.
Perhaps this will give them the baby they've wanted for so long.
Dr. Mars Clinic is one of the best.
Because a single in vitro procedure costs around $5,000, it is an option most people
cannot afford.
Still, Dr. Mars services are in big demand.
Hi, you're interested in our in-the-air program?
The earliest we have is March 17th.
We do have a waiting list for that program.
We have about a year to a year and a half wait right now.
For our frozen transfer.
Don, a physician, and Nancy, a student, are unlucky consumers of the new reproductive
technologies.
With ovulation problems, Nancy's tried hormones, artificial insemination, diagnostic surgery,
and IVF.
This year, she had to give up her job as a flight attendant, one more sacrifice to the
demands of her infertility treatments.
I was very depressed and really wanted to die.
I think that's something that most women will go through.
I don't think it's unique to myself.
At the beginning, when things don't work, you get very optimistic before the procedures.
And then after you get the negative results, you get very, very disappointed.
You become obsessed with it.
You incorporate it into every aspect of your life.
You can't watch TV because of the baby commercials.
You can't go outside because you may run into a lady strolling down the street with
her baby.
We don't have a terminal illness, so it's very hard for people to understand the pain
and the trauma and the emotional depressions that we go through.
Last month, Dr. Mars performed an IVF on Nancy that failed.
There are so many variables that even at the best clinics, in vitro results in a pregnancy
only 25% of the time.
Here's how it works.
Temperature readings pinpoint the day of ovulation when a woman's ovaries will naturally release
an egg.
Hormone injections are given to stimulate the ovaries to produce more than one egg.
When the woman nears ovulation, her ovaries are examined by ultrasound to see how many
eggs are growing.
In IVF, the chance of pregnancy seems to increase if several fertilized eggs are placed into
the uterus at once.
It looks like a Swiss cheese pattern.
The dark spots or the punched out spots are the follicles.
Each follicle should contain an egg.
And you've got maybe six or seven follicles that are developing at this point.
Dr. Mars performs a surgical laparoscopy to collect the eggs just before they are released
by the follicles.
First, he inserts a fiber optic tube, or laparoscope, into her abdomen to see the ovaries.
There's a follicle right down the base of the ovary on the medial aspect.
There's a nice large follicle there, a couple of secondary follicles.
We'll have this first big follicle over on this side and see if there's anything in it.
A needle is used to puncture each follicle and suction out the fluid inside.
The needle is being placed through the follicle wall.
It's fairly tough.
You can see the follicle collapsing now.
The fluid, it's a small volume follicle again.
With luck, this fluid will contain a mature egg.
Four or five eggs like this one are often collected during one laparoscopy.
There's a one to two plus in that last follicle.
Now the husband's sperm is combined with the eggs in a dish.
Then they are placed in an incubator so the process of fertilization can begin.
The sperm surround the egg and try to penetrate its outer wall.
When one gets through, chemical changes are triggered to make the egg impervious to any
other sperm.
This is the moment of conception.
The fertilized egg now begins to grow by dividing.
In three days, if developing properly, it is grown to an embryo containing eight, ten,
or twelve identical cells called blastomeres.
At this stage, the embryo can be placed in the woman's uterus.
The embryos are collected in a small catheter for transfer.
Nancy's laparoscopy a month ago produced seven embryos.
Dr. Mars placed four embryos into her uterus because that has proved to be the optimal
number to produce a pregnancy.
He froze the other three.
Before embryo freezing became an option, doctors felt compelled to transfer all viable embryos,
sometimes as many as ten, back into the patient.
As we've learned how to produce more eggs per patient, we've ended up with more embryos.
Ethically and morally, we felt like we had a new life form and we had no place to put
it.
It was either put it back into the uterus or it would be discarded.
So we felt that we had to place those embryos.
The risk of placing all embryos that developed is a very significant risk of multiple pregnancies
occurring.
Quins, triplets, quadruplets, quintuplets, and that's a very difficult problem to deal
with obstetrically.
This is where the new technology of freezing can make a difference.
Extra embryos can be frozen and stored.
The liquid in each cell of the embryo first has to be removed and replaced with a cryoprotectant,
which prevents the cell from disintegrating as it freezes.
Next, the embryos are placed in a cooling chamber and over four hours frozen to minus
seventy-five degrees centigrade.
This procedure is experimental and there is still much to learn.
At any stage, the embryo is at risk of being destroyed.
Finally, the embryos are stored in a freezer filled with liquid nitrogen.
Nancy and Don now have six embryos in this container, the extra three from her in vitro
procedure and three from a previous laparoscopy.
Today, Dr. Mars will thaw their embryos.
Since in vitro fails so often, a further benefit of embryo freezing is that it gives a woman
another chance at pregnancy without additional surgery.
Well, we just finished the case.
We're going to start thawing now.
We've got two batches of frozen, three in the first and three in the second.
I'm just going to thaw the first ones out first because they're the oldest and we'll
see what they look like.
If they look good, then we won't touch the second group of embryos.
We treat these embryos as human life forms, whether we're freezing them or whether we're
preparing them for transfer to the uterus and we treat them with dignity that we would
treat any other live human material.
The controversy that will come about with embryo freezing is the embryos that don't
survive the freezing and thawing process.
We're only recovering about 60% of embryos that are frozen that look viable when we transfer.
Now Dr. Mars and his assistant begin to thaw three of Nancy and Don's embryos.
Contained within plastic straws, the embryos are brought to room temperature in one or
two minutes.
During the thawing process, we've seen a lot of embryos that initially look fairly
decent that'll look bad after the thawing is complete.
Because thawing, just like freezing, is still so experimental, Dr. Mars doesn't know if
the embryos will survive this step.
It took him 30 tries to get two pregnancies using frozen embryos, and he's still learning
by trial and error how quickly to thaw and remove the cryoprotectant.
See some blast from here, outlines, looks to be fairly intact.
The first embryo seems to have survived.
Now he looks for the other two.
I don't see the third embryo, which probably means that there was damage occurring during
the freezing and the embryo fractured or lysed.
So we're ending up with two out of the three embryos.
It's hard to know whether you're dealing with a viable structure or not.
What we look for is clarity of the cells, the blastomeres, and you can see some blastomere
separation in this one.
I'd like them to look better.
Of course, we'd like them to look as if they were fresh and never frozen.
We haven't done enough transfers with these types of embryos to know whether these will
go on and produce babies after transfer or whether they are non-vival structures.
Don't worry, they look all right.
How many?
Well, we thought out three, and two, we found two of the three.
The third one probably lysed during the freezing process.
But the two look pretty good.
They didn't look real good right at first, but as we've diluted out the cryoprotectant,
we're seeing the blastomere shapes, and they look fairly good.
Good.
Male or female?
There's a boy and a girl.
Good.
They're both looking for moms, so.
The longer you work with an individual couple, the more involved you get in trying anything
that's possibly going to help them achieve their desire, which is to have a child.
So it becomes almost a personal challenge at times to try to take one particular situation
and make it work.
Okay, Julie's got the catheter with the two embryos in it.
Now I'm going to be placing this catheter up through your cervix.
The transfer is usually painless, but because of the position of Nancy's uterus, Dr. Mars
has to hold her cervix steady with the clamp so he can insert the embryos.
I feel a little cramp in the catheters inside the ears, and the embryos are going in there.
Now I'll slowly pull the catheter out.
Are you uncomfortable?
Not too bad.
Okay, the transfer's off, I'm going to take the spectrum out.
There's no leakage of fluid or no bleeding, so you're okay.
But what about a baby born from an embryo that has been frozen and thawed?
Can it possibly be normal?
Until we have a large number of babies by this process, we won't know.
What we do know is that we think it's going to be the same as IVF, and that the risk is
extremely low, because it's an all-or-none phenomena.
If they survive the freezing and thawing, and they develop a pregnancy, they're the
hardiest and the most normal embryos we believe.
Nancy won't know whether or not she's pregnant for another two weeks.
If she is, her struggle to have a child may finally be over.
But she would still have three embryos in the freezer.
What is the fate of unused frozen embryos?
This question made international news when a millionaire couple from California died
in a plane crash, orphaning their two frozen embryos in this Australian hospital.
What does the in-vetro team do with these particular embryos?
Do they simply dispose of them?
Do they give them the chance of life by implanting them in a womb, either to be raised as the
children of the women concerned, or do they use a surrogate mother so that the children
can be raised to maturity to share in the estate of their dead parents?
The case of the frozen embryos fueled a national debate in Australia, where the technology
was first developed and regulated.
Embryos frozen in this country are not subject to any government regulations, so the few
in-vetro clinics that are freezing have established their own guidelines.
But many questions remain.
Should that embryo be given full rights as a person, now that it seems to have its own
independent existence?
Is it proper to transfer that embryo from one party to another?
Does the state have any rights to those embryos if they've been abandoned in a freezer, or
if a couple decide that they don't want to follow through with in-vetro fertilization?
The underlying issue here is the moral status of the embryo.
And because our country is embroiled in a debate over abortion and the question of when
life begins, there is no easy answer.
There it is.
The question is, is that something that is really morally worthy of respect?
Does it have rights?
Is it something that I'm going to try and say has dignity, or is it just a glop of cells,
no different from any other group of organic material?
I'll do with it as I please, depending on the aims and goals that I have.
Dr. Gary Hodgen, an embryo researcher now at the Jones Clinic, hopes to improve treatments
for infertility and is developing techniques for evaluating embryos.
To avoid controversy, he limits his work to animal experiments.
An embryo is split.
The purpose here is to learn how to remove a section of a living embryo.
When and if this technique is tried on human embryos, some will be destroyed as it's perfected.
But the benefits may be substantial.
Human embryos can be screened for genetic defects.
This is just one example of the promise of human embryo research.
It may also improve in vitro fertilization and unlock the mysteries of embryonic development
and cancer.
Yet, because it involves growing human embryos and, after about two weeks, discarding them,
researchers are hesitant to proceed.
I think we're waiting for society to accept that our motives are proper, that they're
approved, that what we're doing, society says back to us, is helpful.
We haven't really had, in my judgment, a national debate of any significance on that subject.
But if we come to a point where we're going to tolerate some kind of research, it should
be, I believe, controlled by an appropriate authority, national in scope, because the
matter is so important.
Traditionally, government has had a hands-off attitude with respect to the family, sex,
and procreation.
It has basically said, in the United States, we don't deal in the areas of reproduction
and sex.
That's a private area.
Remember, the Supreme Court decision on abortion said we will not ban abortions in the first
trimester because that is basically a private decision.
I think the other reason we don't have any science policy with respect to artificial
reproduction is that the regulatory authorities, the government bodies, are too afraid to get
involved with it.
It raises terribly disturbing questions about where to draw the line with respect to research.
What is the moral status of an embryo?
What types of obligations does government have to those who are infertile?
Those are very difficult questions.
Sometimes it's better to avoid a difficult question than to try and answer it at all.
So I think we've got some ostrich-like positioning of certain authorities with respect to this
technology.
The absence of regulations puts individual doctors in the position of making up their
own rules.
Here in Cleveland, Mount Sinai Hospital runs a successful and, until 1983, standard in
vitro program.
Director, Dr. Wolf Udian.
One day I got a most unusual telephone call from a couple out of state making a request
of our in vitro program for something that had not yet been done before.
The idea was to try and get an egg from a woman who'd had a hysterectomy and therefore
unable to carry a pregnancy, a sperm from her husband to fertilize the embryo in vitro
and then to transfer the embryo to the uterus of a friend, a sort of surrogate carrier or
surrogate host situation.
For Elliott, a cardiologist, and his wife Sandy, Cleveland was the last hope.
They had already been to England to see the doctors who produced the world's first test
two baby.
In fact, Sandy became pregnant there after one in vitro attempt.
It seemed that everything was working out and we were going to have a baby.
And then in the seventh month I developed severe pain and bleeding and that necessitated
an emergency c-section and our baby was born at 28 weeks.
She was a beautiful girl, her name was Heather, she was a perfect baby, but unfortunately
she was very premature and though she put up a valiant struggle, after 13 days we lost
her.
At the same time I had a uterine tear and that necessitated that I had a hysterectomy.
Though she still had ovaries, Sandy had lost her uterus and there was no available technique
to help this couple have their own genetic child, but that didn't stop Elliott.
Just one day the thought occurred to me, why not combine existing technologies and do in
retro fertilization with a surrogate?
And when I thought of that I mentioned it to Sandy and I was excited by the prospect
and she was excited by the prospect and then the next task was to really find not only
a surrogate but to find someone who was medically willing to do it.
It was an original idea, Sandy's egg fertilized by Elliott's sperm in vitro and then implanted
in another woman.
Elliott called clinics around the world.
Finally Dr. Udian agreed to take their case, in part because they had a friend willing
to undergo the pregnancy without being paid.
We didn't want an association where we could in any way this would be construed as if you
like dealing or marketing in babies as such and therefore we were pleased with the way
the request had come to us that this was a couple with a friend.
Unfortunately she developed a medical problem that made it really not health wise, a wise
thing for her to do and we had to go on and see what else we could do in terms of a surrogate.
Pairing someone seemed the only option so they ended up here in Detroit where lawyer
Noel Keen runs a thriving business brokering surrogates to infertile couples.
I just wanted to let you know that the couple you met with on Saturday told me this morning
and told me that they would like to work with you as their surrogate.
She's going to take the child from the hospital and give it to the father outside.
She didn't want the hospital to know that she was a surrogate.
Keen specializes in traditional surrogacy where a paid surrogate is artificially inseminated
with the sperm of an infertile woman's husband.
This baby went to Greece.
Here's a couple that lived in London, England and here's their surrogate right in the room
with them.
There's the child.
Yeah I didn't know that they did this.
It was so popular.
I thought it was just now starting.
Now Keen is also interviewing women who want to be in vitro fertilization surrogates.
Most of these couples are of substantial wealth.
They're generally professional people, either lawyers, doctors or successful business persons
that are earning enough money to pay for the costs associated with this program, which
is around $25,000.
The couples will pay you a $10,000 fee.
In addition to that, they will pay all the related expenses.
Expenses include Keen's fee, now $10,000.
He quickly found a surrogate for Sandy and Elliot.
They paid her the standard fee but didn't tell Dr. Udian about the new arrangement.
We thought that if he knew that she was being paid, there was the possibility that he might
not do it and I didn't want to risk that.
So therefore we felt it would be safer not to tell him.
Nor did Dr. Udian ask.
The hospital had already given him permission to proceed.
So based on his original understanding that the surrogate was not being paid, he and his
staff went ahead, but first they had to make one major adjustment to the standard in vitro
method.
From a scientific point of view, what intrigued us about the procedure was there was a challenge
to try and cycle two women concurrently so that they would both be ovulating within 24
hours of each other.
Dr. Udian gave Sandy birth control pills so she would ovulate at the same time as the
surrogate.
The embryo could be transferred when the surrogate's uterus was ready to receive it.
Next, Dr. Udian performed a laparoscopy on Sandy.
She had surgery three times to collect eggs for transfer, but each time the surrogate
failed to get pregnant and finally gave up.
I started getting discouraged myself and it was Sandy who said we should continue and
I felt that since she really was bearing all the risk that I would continue with her.
I was really concerned about how I would feel say in 10, 20 years when I looked back and
I would have thought to myself, well perhaps if I had given it just a little longer, perhaps
we could have succeeded.
It took nine months to find another surrogate.
Sandy underwent one more laparoscopy and a single egg was successfully fertilized.
In August 1985, the embryo was transferred into the surrogate.
Two years and thousands of dollars after Sandy and Elliot came to Mount Sinai, their embryo
began to grow in another woman's body.
For the first time ever, a woman who had no uterus had a chance to have her own genetic
baby.
It was a type of icebreaker for future science, another step in this rapidly evolving science
of reproduction.
Perhaps one of the thoughts that crossed my mind was, considering myself really quite
a traditionalist, would traditional medicine go with this or think that we'd overstepped
the mark perhaps?
When you separate the genetic function from the gestational and the rearing function,
you've done something to untie the biological knot that we call parenthood.
The first commandment in the Old Testament is to be fruitful, multiply, and further land,
which means to have children, and I can't see how anyone can think that fulfilling the
first commandment in the Bible is unethical.
Sandy and Elliot had to wait nine anxious months while another woman a thousand miles
away carried their child.
And they were troubled by legal issues.
Would they have to adopt their own baby?
What would happen in the unlikely event the surrogate refused to give it up?
Their legal position was uncertain.
I think the million dollar question is, who is the real mother?
Because we're dealing with a situation as this type of medical science advances where
you can have four or five parents by some or other definition.
In this particular situation here, we have a genetic mother, that's the wife, who's
given the egg.
We have the carrying mother, who is the surrogate carrying the pregnancy.
For the most part, we've legally presumed mother.
We haven't even defined it.
We're saying the woman gives birth to the child, it must be her baby.
It's not true anymore.
And we have recently filed a lawsuit in Michigan asking the court for the first time to give
us a legal definition of motherhood.
The court ruled that in Sandy and Elliot's case, Sandy was the legal mother.
They wouldn't have to adopt their baby and were protected if the surrogate changed her
mind.
It's Christmas in Cleveland, 1985.
Sandy and Elliot's surrogate is four months pregnant.
With everything going well, Dr. Udian wants to offer surrogacy as part of his regular
in vitro program, but first he must seek the approval of several hospital committees.
Udian has proposed that the hospital only work with unpaid surrogates.
On the other hand, we've had some offers of people who would offer for financial reimbursement
to carry a pregnancy.
And I'm just wondering how far away you would see perhaps a couple who, perhaps out of some
sort of inconvenience to their careers or just lack of a desire to want to go through
with a pregnancy, but they have plenty of money to find somebody to bear their genetic
child.
I personally find the idea of using somebody else to carry a pregnancy because it's inconvenient
being distasteful.
So I doubt that our program would ever offer something like that.
You know, remuneration sounds fine.
Heart nurses, for instance, are paid to take care of infants and other nurses are paid
to take care of small children, of course.
So I think that there's nothing sinister about the idea of remuneration.
How many institutions have approved programs in the country today?
We're probably the first one.
Other existing in vitro programs have been referring requests of this nature to us because
they haven't got into this particular issue yet.
I think many of them are actually looking at us as the so-called icebreaker.
Let's take it then one at a time.
The surrogate host program, all in favor, raise your hand, say, opposed.
We then have an approval by the...
To Udian surprise, the hospital has approved of in vitro into paid surrogates, a decision
that will bring them prominence.
But in breaking new ground, these men have set a controversial precedent.
The possibilities for abuse are just a hundredfold.
You can see poor people who have no other way of getting money, renting out their wounds.
Well, this is a reduction of a woman to a function.
It has been possible for centuries to sell women for sexual services in sexual prostitution.
It is now possible to sell women for reproductive services in reproductive prostitution.
Prostitution was basically made illegal in some other countries because they felt that
it was wrong to commercialize procreation.
You may hear and others may argue that further reasons were involved about enforceability
of contract and the difficulties in knowing exactly who was the party of responsibility.
But I really believe it was the commodification, the commercialization of procreation that
led to a kind of moral repugnance.
Now, the United States hasn't shown itself to be as equally repelled by commerce and
business and profit when it comes to dealings among human beings.
Nor has the government been ready to involve itself in the growing field of reproductive
technologies.
In 1979, the Department of Health and Human Services made a feeble attempt by establishing
an ethics advisory board.
Its report approved in vitro fertilization and related research on the early embryo.
It even recommended federal funding under certain conditions, but these recommendations
have been ignored by government officials.
Father Richard McCormick was on that board.
First of all, it's a political hot potato, very controversial.
The mail that was received after our recommendations appeared in the federal register, where mail
was overwhelmingly negative.
There is a natural tendency on the part of people in public service to shy away from
issues of this kind.
Add to that the fact that our nation is involved in a very turbulent debate about the implications
of abortion with the battle lines drawn very clearly.
When you get a volatile mixture and the path of least resistance is for people to say I
don't want to have anything to do with it, just keep it out of the public area altogether.
The National Institutes of Health support biomedical research.
When the 1979 recommendations failed to become policy, the result was a de facto moratorium
on funding any research related to the new reproductive technologies.
The moratorium continues today, and in this area no funding means no regulation.
One of the terrible problems of having no regulation and no public discussion is that
there's absolutely no way to control anybody's desires and purposes with respect to this
technology.
So if someone wants to use it for eugenic purposes, if someone wants to open a Nobel
Prize sperm bank, if someone wants to open a surrogate mother's farm, they go about it
and do it.
Certainly when a new medical technology is introduced, there's some government funding,
either federal funding, state funding, but since this is such a controversial area and
since the federal government has refused to fund, the practitioners have been forced to
seek funding from commercial sources.
This can lead to problems when the bottom line dollar becomes more important than patient
concerns.
It's October 1985, and financial printers are producing a prospectus for Fertility and
Genetics Research, FGR, a Chicago company trying to start a business of making babies.
Investment banker Larry Soussi is chairman of FGR.
He and his lawyer are completing the document they need to sell stock to the public.
If Soussi can raise $4 million, he can market a new technology called non-surgical embryo
transfer.
He became interested in the idea seven years ago.
I thought immediately that this would be an important technology with a lot of extensions
that dealt fundamentally with us as humans.
The power of reproduction, the need to reproduce, dealing and working with basic procreation.
I said, if you can do that, transfer an embryo from one woman to another non-surgically and
make it medically viable, that is terribly important and will be.
The embryo transfer technique was first developed in the cattle breeding industry to increase
the production of high quality stock.
The embryo of a prize cow is transferred into the uterus of an ordinary one which carries
the calf to term.
This way the prize cow can produce 18 or more offspring a year.
Soussi and others banked on the idea that embryo transfer could be applied to humans.
This technique could help a woman with tubal and ovulation problems or whose eggs contained
a genetic defect.
Another woman could donate an egg to be fertilized by the husband through artificial insemination.
Five days later, without surgery, the embryo could be flushed out of the donor's uterus
and transferred to the wife who'd have the experience of pregnancy.
Here the mother is the woman who gives birth to a baby, not hers genetically.
It seemed simple, but it would take Larry Soussi three million dollars from private
investors to make it work.
For medical know-how, he contracted with a team of researchers from Harbor Branch UCLA
Hospital in Torrance, California.
Dr. John Buster is an endocrinologist who became interested in the area of reproductive
technology after the birth of the first test tube baby.
He welcomed a research project in this field and a source of funding for the work.
In the late 1970s, there was not a brass penny available from the federal government for
work in a field we thought was supremely important.
There had been decisions made by the politicians that the field was not fit to support for
a lot of important reasons.
So we looked at two things.
One was how we could enter the field differently, and the other was how to enter it in a financially
responsible way, since I can't work and my people can't work for free.
So we think her husband's all right, so we can probably proceed.
The question is how long her tubes are.
Dr. Maria Bustillo also played a central role.
The catheter used to flush the embryo out of the uterus had to be adapted from cows
to women.
Basically, when we started out, we thought the simple catheter, very similar to the cow,
would work easily, but that turned out not to be the case, because the woman's uterus
is quite different from the cow.
The main difference being that in the cow, one can put lots and lots of fluid and not
have to worry about it leaking out of the uterus, and one can then retrieve that fluid
easily.
In the human, however, the uterus is quite small.
The inside or the cavity of the womb leaks.
That is, if you put any amount of fluid with pressure in it, it will go out the fallopian
tubes and into the abdominal cavity.
That obviously would not be worthwhile to do, because then one would lose the embryo
out into the abdomen or not be able to retrieve the embryo.
Therefore, the catheter had to be greatly modified to be able to accomplish what we
wanted.
Essentially, the catheter is fairly simple, and only this plastic part goes inside the
uterine cavity.
It works very simple in that fluid is injected through this inner tube, smaller one, into
the uterine cavity, and then it is sucked out through the larger tube into this flask
where we recover the embryo.
Developing the instrument was only the beginning.
Could they get anyone to donate an egg?
Over 100 women responded to this ad, which offered as reasonable compensation $250 a procedure.
In 1982, experimental trials began with nine anonymous donors matched to 12 infertile couples.
Using the special catheter, the uteruses of the donors were flushed out, a process that
Dr. Bustillo acknowledges has some risks.
Because it is a procedure that you technically introduce something into the uterine cavity,
and any time you do that, there is a small risk of infection, so that's the first risk.
The second risk is that we do not get the embryo and the donor becomes pregnant, and
that actually has happened to us twice in the same woman, and that is a risk we have,
and we only recover embryos about 50% of the time, and so that some of them might implant.
We don't think that's likely because I think the catheter does a pretty good job of washing
it, and it probably disturbs the lining enough, so that implantation is very unlikely to take
place, but that is a risk.
The next and other risk is that the egg never got there and is stuck in the fallopian tube,
which can happen normally, and or that we pushed it out into the fallopian tube, and
the patient would then have an ectopic or a tubal pregnancy that would have to be taken
care of surgically.
From 52 flushings, 25 embryos were recovered and transferred.
At last, in January 1984, a success.
The eyes of the medical world are focused on Harbor UCLA Medical Center tonight, where
human history has once again been made.
Pregnancy was uneventful, it was absolutely healthy, the child was in robust condition
at birth and went home healthy, as did the mother.
In spite of the publicity and the birth of the second baby, embryo transfer came to a
halt two years ago.
FGR ran out of money and the research trials ended, but letters poured in from more than
3,000 infertile couples waiting for the procedure.
Now the challenge was to raise money to open clinics around the country.
After failing to find private capital, FGR decided to sell stock and go public.
In November 1985, Susie and his investment counselors took to the road to present FGR
to brokers around the country, Chicago, Seattle, Los Angeles, New York, and today, Boston.
One reason FGR can sell stock is that they have a major asset, a patent on the special
catheter and a patent pending on the embryo transfer process itself.
We simply set about to do what every technology company does, and that is to get the best
patent protection possible on the technology being developed.
And that included, of course, the tools being developed and the process itself.
Can you imagine the situation where physicians went out and said they were going to apply
for a patent for hysterectomy and appendectomy and every minor procedure that existed, and
that someone would have to pay royalties to somebody else for actually doing an operative
procedure on someone?
It's a nightmare situation.
It would be out of control.
It's never been that way.
The situation in terms of sharing of knowledge has worked extremely well up to this point
in time, and I think to create a precedent of allowing a medical technique to be patented
would be about the single worst thing the U.S. Patent Office could do.
We have an obligation to our investors to protect the technology that we've developed
and retain that within the company.
The difficulty is that the procedure is so experimental and has such relatively poor
outcomes still with so few babies being produced out of many efforts that to talk about patent
at this point is to change something into a therapy when it's still basically research.
We are looking, we believe, at about 70 to 90,000 procedures annually.
FGR makes a strong sales pitch to a group of Boston stockbrokers.
About 15,000 of those, of the 70 to 90,000, will be able to afford one to four tries which
will cost approximately $12,000.
How do they plan to tap this affluent market?
By selling the technology to clinics who will pay them a royalty.
We do not like the use of the term franchise as connected with this technology because
that implies an analogy with hamburgers and where people take something away and simply
pay you something and utilize it.
We think this requires extensive quality control, extensive consistency of the medical protocols,
continued involvement by our medical people because if someone should have an unfortunate
misadventure it would reflect on all of us and on the whole technology and we don't
intend to permit that to happen if we possibly can.
The issue of liability is coming up.
If we are providing embryos to women, are they products or is it a service?
If it's a service, the liability is one thing.
If it's a product, it's another.
But the demand for this technology is just incredible and I think the system will iron
it out.
It's an intensely exciting time for this work that we're doing.
And a high-margin business.
Oh, well there's no limit on that.
It would be such an opportunity to give.
We've had some donors write in and say, I'd be glad to share the gift of life.
I have done 50 public offerings.
I have participated in hundreds of other and I've never seen a deal structured for a venture
capital deal structured to the benefit of the public investors this is.
Baby You, FGR's trading symbol, appeared on the market six weeks after they began selling
shares.
Their public offering was a success and now that they have four million dollars in the
bank, they must identify a pool of fertile egg donors so they can open clinics.
The fertility of the donors is maximized by choosing the right ones.
There are some women who become pregnant at the drop of a hat and those kinds of women
will be very effective and efficient donors.
FGR had hired a market research team to design this ad and survey the availability of women
willing to serve as regular donors for $250 a procedure.
At the new company's first board meeting in December 1985, the report was a major item
on the agenda.
We retained the firm of professional practice builders because we all recognize that the
recruitment of appropriate donors and adequate numbers of donors was central to the success
of the company and Richard Bernstein of professional practice builders is going to summarize that
for the board today.
The medical technology is a given.
You've created and developed and have proven that this non-surgical embryo transfer is
state of the art.
It works.
It's wonderful.
But that doesn't translate into getting one woman to say, I will toss away all my concerns
and my ethics and my morality and the advice of friends and relatives or my physician and
share my fertility.
Can you in fact retain a significant number, let's say 50 donors for each market that the
program would go in?
That was the essence of what we were there to find out.
And I bring you, I think, good tidings, absolutely and unequivocably, yes.
The tremendous opportunity that this company has for business growth quite simply is reflected
because your primary resource for that growth, the donor woman and her fertility, exists
in a cost-effective abundance.
And I can't state that strongly enough.
Now how we plan on going about it.
First of all, I want to thank all those people who have made this possible.
It's great to be here tonight.
But above all, I want to toast the first 1,000 mothers and their children that will come
from this process.
A toast to those first 1,000.
Dr. John Buster, now a vice president and stockholder, hopes FGR has a bright future.
But some people are concerned about their plans.
I think there's difficulty in franchising and commercializing any aspect of medicine,
especially a very sensitive area such as infertility therapy.
Patients are very driven to have a child.
And when you take that into consideration and the fact that they'll do anything to
have a child, then manipulation of those couples can occur.
We genuinely feel that no aspect of what we are doing is in any way inconsistent with
what else is going on.
Food companies have always been among the highest return on investment industry.
And physicians are the single highest paid group of individuals within our country.
In 1984, Representative Albert Gore held congressional hearings to look into commercialization and
other issues raised by the new reproductive technologies.
Since the federal government turned you down and since you were forced to go into the private
sector to get the money...
Two years before Dr. John Buster became a vice president of FGR, he testified as one
of the expert witnesses.
The source of private financing requested in return for their money, is that...
Their motivation is not to withhold it, it is open it.
And make more money from it.
And the way that they make money from it is through the payment of royalties, which is
simply a system for paying back on investment.
Well now in fact, your sponsors, you and your sponsors have in mind having embryos flown
from city to city where and when they are needed on a nationwide basis and making a
rather large business out of it.
That's what you have in mind, isn't it?
They do have plans like that.
What I have in mind is to be a scientist and do my research work.
Yeah, that's what your business partners have in mind.
This is what our sponsors have in mind and it does sound like a big business because
a lot of work needs to be done.
A lot of women out there that want these babies.
A year after these hearings, Congress established an ethics board to examine issues raised by
the new reproductive technologies and other biomedical advances.
But because these areas are still so controversial, the board may not get the support it needs
to deliver its recommendations by its 1989 deadline.
And even if it does, will this committee succeed where others have failed?
The British tried to regulate the technology by setting up a national commission.
And I think they got themselves in trouble because the commission did a very conscientious
job in examining the many ethical questions raised, but it didn't have enough political
and social support for its conclusions.
Other people weren't brought into that dialogue.
In the United States, we haven't had any commissions.
We haven't had anybody attempt to do a systematic analysis of the consequences of this technology.
But that may be in our advantage if we take the time as a society to try and struggle
a little bit with the answers to questions like, what priority should we give to fertility?
Do we all understand the need to do some more research on embryos if we're going to perfect
this technique?
What sorts of conditions are we going to put on experimentation with respect to embryos?
And so on.
We need to lay the groundwork for regulation, but regulation must come.
On April 13, 1986, Sandy and Elliot's surrogate delivered a healthy baby girl.
They were handed their daughter at birth and left the hospital the proud parents of their
own child.
All that we've gone through, all the ups, all the downs, now that I have the baby, it's
all worth it.
It really is a dream come true.
And we really do hope that we can give hope to other couples.
Nancy did not get pregnant with her first batch of frozen embryos or even her second.
A further in vitro attempt also failed, but left her with more embryos in the freezer.
She and Don plan to keep trying, but just in case, they've hired a surrogate.
I actually feel very fortunate because at this time I have alternatives that 10 years
ago women did not have.
I can go through in vitro, I can go through a frozen embryo transfer, I can seek surrogacy.
My aunt who had the same problem that I do is childless because the alternatives were
not there for her.
This is where it all began.
Elizabeth Carr, America's first test tube baby, is now four years old.
Because what the new reproductive technologies produce is so precious and in such great demand,
it seems that they are here to stay.
But who will make the rules, doctors and their patients, the federal government, the marketplace?
As we avoid making the difficult decisions, the techniques could develop in directions
we may not want.
So much has happened since the birth of Elizabeth Carr.
What will reproduction be like when she is ready to have a child of her own?
I'm going to make her a pie, little bear, little bear, little bear, little bear, little
bear, little bear, little bear.
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