Abortion Drug RU486
Made in China?
By Randall K. O'Bannon, Ph.D.
NRL Director of Education and Research
With the FDA poised on the threshold of deciding whether to authorize American marketing of RU486, new information has come to light on Danco Laboratories LLC, the secretive for-profit pharmaceutical firm started and licensed by the Population Council of New York to market the abortifacient in the U.S.
Internal corporate documents reviewed by the Wall Street Journal (9/5/00) reveal a ream of important details about Danco, its structure, its investors, and its plans for marketing RU486 in the U.S. The Wall Street Journal also uncovered what could be Danco's dirtiest little secret that the drug may be being manufactured in Communist China, the land where the ideology of population control is so strong that women pregnant with a second child have often been forced to abort their babies to comply with the government's "one child" policy.
Background on Danco
While Danco Laboratories LLC is now publicly identified as the marketing arm of the RU486 project, it really is merely the latest incarnation of a raft of secret companies set up by the Population Council to handle various aspects of U.S. RU486 effort. (The Population Council holds the American patent for the abortifacient.)
First was Advances in Health Technology, a non-profit the council established to promote the drug and handle physician training. Advances granted manufacturing and distributing sub- licenses to two other for-profit companies set up for that purpose, Danco Laboratories and Neogen Pharmaceuticals.
Following lawsuits and corporate restructuring, Advances in Health Technology became Advances for Choice, and then Advances/Neogen, with the functions of the various entities rolled into one.
Reports in 1999 and 2000 began to refer to the Danco Group, rather than Advances/Neogen, as "the company licensed to market RU486" or "the company sponsoring mifepristone in the United States." Other 2000 reports, including the latest one from the Wall Street Journal, have identified Danco Laboratories LLC as the firm marketing the abortion pill in America.
Danco is not believed to have any other product besides RU486. Occupying the 13th floor of a Manhattan office building, with an unlisted phone number, the Wall Street Journal says Danco has avoided the spotlight, spending its time raising money for the RU486 project, finding a manufacturer, seeking government approval for the drug, and resolving internal conflicts. Danco is headed by former Merck & Co. marketing executive Roy Karnovsky.
Financing and Marketing the Abortion Pill
Danco raised about $34.7 million for the RU486 project through March 2000, the Wall Street Journal indicates. It largest supporters have been foundations established by well-known advocates of population control, such as Warren Buffet and George Soros, wealthy Wall Street investors, and the late David Packard, one of the co-founders of Hewlett Packard, the computer and printer giant.
Other investors, which the Wall Street Journal does not identify by name, include a Nashville country-music producer, a San Diego doctor turned entrepreneur, and a New Jersey businessman.
Danco has used some of this money to establish training programs and set up a marketing campaign. The Wall Street Journal reports that approximately 1,200 "providers" have already been trained to use RU486 by the National Abortion Federation with money provided by Danco, and Danco has plans to spend at least $1.2 million to teach doctors, counselors, clinicians, and other medical personnel how to properly administer the drug.
The Journal's account reports that Danco has hired a Seattle firm, DDB Worldwide, to develop advertising for the drug, which it plans to market under the name "Early Option."
The China Connection
While raising money for the controversial project has been difficult, the biggest problem for Danco and the Population Council has probably been finding a manufacturer for the abortion pill.
Though it granted the Population Council the U.S. patent rights to RU486 in 1994, French drug maker Roussel Uclaf did not want to be involved in manufacturing the drug for the U.S., forcing the Population Council to look elsewhere.
The Population Council thought it had found a manufacturer when it contracted with Hungarian drug maker Gedeon Richter in 1996. But that deal fell through in early 1997 when Richter told Danco and the Council it wanted out of the deal.
Danco and the Population Council let it be known to friendly media outlets that they had found a new manufacturer in early 1999, but did not offer details as to who this manufacturer was or where it was located. The Wall Street Journal report suggests that Danco has contracted with a Chinese manufacturer to produce the drug for U.S. consumption. The Chinese association is problematic for a number of reasons. First, the Chinese developed their version of the abortion pill in the 1980s after copying the pill produced by the French. Whether this has the same chemical formula, whether this has the same level of "safety" or "effectiveness" as the French pill, whether it has the same risks and provokes the same side effects, or worse, is not clear.
Second, another huge challenge would be the ability of Danco and the Food and Drug Association (FDA) to monitor the production process in a distant, totalitarian country, with a notorious human rights record, particularly when it comes to state- mandated abortions and sterilizations.
The Wall Street Journal reports that the FDA was scheduled to have inspected a manufacturing plant for Danco in July, but does not say whether this was the Chinese plant or some other location. Efforts by Danco to get a second back-up manufacturing site going, at some other undisclosed location, have met with production problems including "poor yields" and "high impurities." In any case, documents examined by the Wall Street Journal indicate that whatever Danco's future manufacturing plans, it still plans to pay at least $293,363 through the end of the year to one of the several Chinese manufacturers currently producing RU486.
Projecting RU486's Future
If RU486 receives FDA approval, the Wall Street Journal says Danco estimates it would sell about about $3.7 million worth of pills by the end of 2000. If Danco's projections hold, that figure would increase to $34.2 million by 2004.
Those same documents predict that RU486 would be used for 29% of all U.S. abortions after four years on the market, or by another counting, 53% of all U.S. abortions performed within the first eight weeks of pregnancy.
If so, American use would mirror that of France, where about a third of all abortions are performed using RU486.