After the controversy that surrounded its approval in September of 2000, mifepristone is struggling for acceptance in the U.S. market. Part 3 in a series.

Present and future availability
As a health policy issue, mifepristone continues to attract controversy, but its status and availability have been unchanged since September 2000. 

Mifepristone is not dispensed by prescription from pharmacies. It is supplied directly to qualified physicians, who give it to their patients on site. Physicians who dispense mifepristone to their patients must be able to accurately date pregnancies to ensure that the drug is not given to a woman whose pregnancy is more advanced than 49 days--or up to 9 weeks in some protocols. Dispensing physicians also must be able to diagnose a tubal pregnancy. Because a failed medical abortion generally necessitates a surgical abortion, providers either must be qualified to perform surgical abortion or must arrange with another provider to perform any necessary surgery. Dispensing physicians must also be prepared for a possible need for emergency medical care. 

At one point prior to the approval of mifepristone, the FDA was reportedly considering restricting use of the drug to doctors who are also qualified to perform surgical abortion. This restriction would have effectively made medical abortion available only at facilities that currently offer surgical abortion and thus done nothing to improve women's access to abortion services in general. The final approved labeling for mifepristone did not include this limitation, but bills to impose the restriction have been introduced, rejected, and reintroduced, most recently by Senator Tim Hutchins (R-AR) and Representative David Vitter (R-LA). 

Upon his recent appointment to office by President George W. Bush, U.S. Department of Health & Human Services Secretary Tommy Thompson pledged to review the safety of mifepristone, but no such initiative has yet been mounted. 

Slow to catch on
A recent story by Denise Gellene in the Los Angeles Times (May 31, 2001) notes that the response of the public and the medical community to mifepristone, postapproval, has been somewhat underwhelming. For example, the Planned Parenthood Federation branch in Los Angeles reported earlier this year that only 1% of its clients were choosing mifepristone. Among the possible reasons, Gellene notes that a medical abortion with mifepristone typically costs from $75 to $130 more than a surgical abortion. The experience of Planned Parenthood of New York City corroborates the notion that cost is a factor. The New York branch charges $375 dollars for an abortion, regardless of method, and their reported rate of acceptance for medical abortion is 12%. Planned Parenthood of New York City also ran a $50,000 ad campaign in the city's subways earlier this year to raise public awareness of the medical abortion alternative. 

In order to raise public awareness of the availability of medical abortion nationwide, the National Abortion Federation has been running an ad campaign in Self and People, with follow-up ads in 11 other magazines. The cost of the campaign is $2 million, and it is expected eventually to reach 70% of women in this country between the ages of 18 and 49. 

Other possible explanations for the sluggish acceptance of mifepristone include the fact that surgical abortion only takes minutes to complete, while a medical abortion generally requires three visits over 14 days. Lengthy counseling is required for medical abortions, and the provider must generally be available to his or her patient at all times for emergency care. 

Dr. Richard G. Roberts, president of the American Academy of Family Physicians, points out that a typical family doctor will only have one or two requests for abortion per year, which raises the prospect of the doctor buying mifepristone to have on hand, only to see it expire before being used. The U.S. distributor of mifepristone charges doctors $270 for the recommended 600 mg dose. For comparison, the equivalent dose in France costs $40. 

It is interesting to note that in France, where medical abortion with mifepristone has been available since 1988, mifepristone is used in only about 10% of that country's estimated 200,000 annual abortions. In Sweden, on the other hand, about 40% of abortions are medical abortions with mifepristone. Where the U.S. rate of acceptance will eventually settle remains to be seen, but it appears unlikely that medical abortion for early pregnancy (less than 9 weeks) will replace surgical abortion anytime soon. 

Future uses for mifepristone
Antiprogestins such as mifepristone are thought to have broad therapeutic potential. More than 400 possible antiprogestins have been synthesized, and many are under scientific investigation. Antiprogestins have shown value as ordinary contraceptives and as emergency contraceptives. Mifepristone shows additional promise in the area of reproductive health as an agent to "ripen" the cervix and induce labor. 

Antiprogestins have proved effective in the treatment of endometriosis, in which a woman's endometrial tissue begins to grow outside the uterus, and in the treatment of uterine fibroids--benign tumors in the pelvic region that can grow to remarkable size. Fibroids are among the most frequent reasons for surgery in women of child-bearing age; they are the number one reason for hysterectomies. Antiprogestins have been shown to shrink fibroids. 

Antiprogestins may also be useful in the treatment of prostate, breast, and ovarian cancer and in meningiomas--nonmalignant but life-threatening tumors that arise in the membranes surrounding the brain (meninges). 

Mifepristone is an antiprogestin and an antiglucocorticoid; it binds to cortisol receptors, blocking the action of cortisol. As such, it has been shown to be effective in the treatment of Cushing's Syndrome, a condition in which the body over-produces cortisol. In a study by the National Institutes of Health, gravely ill patients with Cushing's Syndrome and inoperable tumors were treated with mifepristone. Over half experienced reversal and control of their disease. The vast majority of people with Cushing's Syndrome are women, most in their 20s to 40s. 

The antiglucocorticoid properties of mifepristone suggest it may also have potential in the treatment of AIDS, depression, alcoholism, substance abuse, anorexia nervosa, ulcers, diabetes, Parkinson's disease, multiple sclerosis, and Alzheimer's disease.