RU puzzled, fed up?


Dorothy Guellec

Last

Thursday, September 28,2000, the landscape for abortion really changed. It has

been a long time coming. The pill called RU-486 was developed in 1980. and in

1982 the first successful human testing was reported in France. After 10 long

years of promises American women will surely benefit. “Finally, American women

can benefit from this product,” said Edouard Sakiz, former head of the French

drug company Roussel, which put the pill on the market in France. RU-486 is now

widely available in Western Europe and even China, but 12 years after it

appeared it is far from the method of choice in the countries where it is

authorized, and it remains controversial in others. That being said 500,000

women have benefited from this non-invasive, private and relatively cheap method

of inducing a mis-carriage, where the expelled matter would be the size of a

grain of rice. It will probably cost $700 in the U.S. and some HMO’s may not

cover it. It is $66 in Spain and $200 in France fully reimbursed by their

systems.

The

history of RU-486 is a tortured one. In 1973 Roe v. Wade, followed by years of

waiting until 1982 when Roussel Uclaf reported the first successful human

testing. In 1983 the Population Council, set up almost 50 years ago by John D.

Rockefeller III to address the problem of overpopulation, received the FDA

approval to test the drug (mifepristone) in the U.S. During the next 6 years,

more than 300 received RU 486 at the University of Southern California.

September 1988 The French Health Ministry approved RU 486 combined with

prostaglandin for medical abortion. The following month Roussel Uclaf suspended

distribution because of pressure from antiabortion groups. After the Ministry

ordered them back on the market the following year they became available. In May

1994 Roussel Uclaf donated the U.S. patent to the Population Council. In March

1996 the Population Council filed a new drug application with the FDA. February

1997 the Hungarian pharmaceutical company Geodeon Richter backed out of an

agreement to make the drug.  April 9, 1997 Roussel UCLAF abandoned the pill

to the researcher Edouard Sakiz for “zero franc zero centime.” The FDA

approved the drug in September 2000. There is much more to the story but these

details do not add very much.

The

RU-486 3 pill regimen in my opinion is safer because it can be used within the

first 49 days. In fact it can be used almost immediately after a woman discovers

that her cycle is off. It is also non-surgical, private, and patients can avoid

the emotional and psychological feelings associated with anti-abortionist

zealots and their tactics that are often violent.

As

to the ethical question that has plagued us for years, namely when does human

life begin, there are many answers to that. Hospital ethicists define the

beginning of life 1) at conception 2) at quickening or when the mother feels

movement 3) when the unborn child is viable 4) at birth. Pro-life people do not

subscribe to these definitions. For them life begins at conception which might

be within 24 to 72 hours.

But

survey after survey has found that most Americans (not so-called pro-life

people) prefer early interventions and feel most comfortable with this idea.

There is a sub-text to all this which may not emerge in the media. The very fact

that horrible pictures no longer characterize abortions (with the use of RU-486

in early stages the embryo is barely the size of a grain of rice) will hopefully

change the entire picture of abortion and wipe away both the stigma and guilt.

If

one can believe the AP (Associated Press) they reported October 3rd “Health

Insurers have generally agreed to cover the newly approved RU-486 abortion pill,

according to a survey of leading managed care plans.” The price has not been

set on Mifeprex (the brand name) though doctor visits and counseling are

expected to run about $700. I would bet my life that this is cheaper at Planned

Parenthood because they have a sliding scale. Covering new drugs is tricky and

when the FDA approves a new drug there is a managed care review before deciding

whether to cover it. This 3-pill regimen is different because it is dispensed

directly from a physician’s office and not through a pharmacy. Some managed

care plans have decided to cover it and others are not sure as yet. It

wouldn’t be cool to try and second-guess their motives but I wouldn’t rule

out politics.

Is

it a mere coincidence that 6 weeks before the Presidential elections RU-486 is

approved and once again reappears on the horizon? Rhetorical question, bien sur

but the political game continues infused with fresh blood (no pun intended). So

27 years after Roe v. Wade legalized it the U.S. remains the only so-called

modern western country where the abortion question raises so much hatred and

death threats.

I

spoke with a CEO at Planned Parenthood for Westchester and Suffolk counties. She

told me this morning (October 4th, 2000) that the pills would not be available

before Thanksgiving, so other media reports of one month are really not valid at

this time. In New Mexico Planned Parenthood said “about six months. In the

meantime the FDA is trying to implement restrictions but The American College of

Gynecologists and Obstetricians co-signed a letter written by the AMA last

summer objecting to the restrictions, and requesting a meeting for July 24,2000.

The letter said that restrictions imposed “inappropriate conditions on the

practice of medicine and that the FDA has no authority to require such training

for physicians who prescribe RU486.” If you go looking for this in the Federal

Register or Congressional Record, there isn’t much to be found, considering

its “controversial” nature.

Right

now it is too early to predict anything for sure. It seems that the total price

will be the same as a so-called surgical AB (abortion) = for a long time =

market power and the ability to affect prices = someone exerting power = OB/GYN

types? Who knows? One cannot mysteriously have the price of the drug equal to

the price of surgery.