By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research
Editor’s note. Elsewhere on NRL News Today, we report on the decision of Health Canada to allow the distribution of the two-drug chemical abortion technique, RU-486. It will be called Mifegymiso in Canada.
Dr. O’Bannon wrote the following very important story last September. In light of the decision by Health Canada, it very much bears re-posting.
If there wasn’t enough confusion already, we now find that the abortion drug mifepristone (the generic name for RU-486) is being produced in other countries and sold under other names. Why does that matter?
It’s a wake-up call for anyone who thought that the abortion pill was just about adding one other boutique abortion option to American clinics. What is clear now is that chemical abortion has become big business, on a global scale, and a lot pharmaceutical entrepreneurs are looking to cash in. And they don’t care much about the risk these online drug stores pose to women in countries all over the globe.
Mifepristone originally was named RU-38486, as it was the 34,486th chemical compound synthesized by French pharmaceutical maker, Roussel-Uclaf. Calling it RU-486 is a matter of shorthand, though it also has the unintentionally ironic feature of being an abbreviated textual form of the question “Are You For 86?” To “86″ something has long been American slang for getting rid of that thing or person.
Mifepristone was first developed in 1980 and went on the French market as an abortifacient in 1988, followed by Britain in 1991 and Sweden in 1992. In Europe, it has been sold as Mifegyne and the company producing it there underwent a number of mergers and changes until rights were transferred to a new entity called Exelgyn headed by a former Roussel executive.
Rights in the United States went to the Population Council of New York, which set up a distributor called Danco and contracted with a Chinese manufacturer by the name of Hua Lian. Once approved, mifepristone was sold in the U.S. as Mifeprex, though it sometimes marketed as “The Early Option” pill.
It wasn’t very long after Roussel researcher Etienne-Emile Baulieu announced his discovery of mifepristone that others began working to make copies of the abortion pill. China announced its own version of mifepristone the same year that sales began in France (1988). Four different pharmaceutical firms began marketing the drug in India shortly after it was approved there in 2002.
Original patents expired years ago, swinging the doors wide open for manufacturers of generics. None are known to exist for mifepristone in the United States, but there are multiple Indian and Chinese firms advertising and selling abortion pills on-line.
One website listed 18 different names for mifepristone sold by 15 different Indian firms. Our research uncovered at least thirteen additional generic versions and brand names as well as several additional companies (see list below).
Several different generic mifepristones come from China, too, from different companies (though one, the New Hualian company, looks suspiciously like the firm that supplies mifepristone to the U.S.). There are also versions from the Russian Federation, Taiwan, Vietnam, and the Republic of Georgia.
Several of the names of these pills are so bizarre they would be comic, were their intent not so deadly – Abortom, Termipil, Undo, Nopreg, Unwanted.
Whether this list gives a full and complete picture of all the producers of mifepristone is difficult to say.
This information alone raises many questions. What relationships exist between the various distributors and manufacturers? Is the Cipla in Vietnam just a subsidiary of the global Cipla pharmaceutical company headquartered in Mumbai (Bombay, India)? Why do certain companies appear to produce the same pill under the different names, e.g., Bi Yun and Zi Yun, both by China’s Renfu Pharmaceutical?
Exelgyn still exists and is listed as the producer of Mifegyne for much of Europe. However it was acquired by the Nordic Pharma Group in 2010, which is listed as the manufacturer for other European countries (Germany, United Kingdom, Finland). It also appears to be some part of the mifepristone pipeline for other sellers like Istar in New Zealand, Cosan in Switzerland, and Laboratoire Macors in Estonia.
Exelgyn tried to keep a generic competitor, Linepharma, from setting up shop in France, but was unsuccessful. ;
Linepharma’s entry into the field is significant, especially now that it has partnered with WomanCare Global, a “women’s reproductive health charity” to provide mifepristone in seven European and seven African countries (none specified in the WCG 2/8/12 release).Linepharma is also lined up to supply abortion pills for Australia.
One would assume that generics are pure and chemically identical to the original, but this is not necessarily the case. On March 9, 2010, the FDA issued an official consumer safety alert, warning would be buyers “Don’t buy these drugs over the Internet or from foreign sources.” One of the drugs featured on the list was “Mifeprex (mifepristone or RU-486).”
The FDA warned consumers that these drugs were available in the U.S., “only under specially created safety controls.” Those safety controls are “bypassed” if bought over the internet or from other countries, “placing patients who use these drugs at higher risk.” The FDA cautioned that drugs bought from foreign sources are “generally not FDA approved.”
Earlier this year, Consumer Reports (4/25/14) reported on an FDA crackdown on Indian pharmaceutical companies selling drugs online to patients in the U.S. Sun Pharmaceuticals, the manufacturer/distributor of mifepristone products Medabon and Mifeprin, was one of those subject to sanctions.
India and China, two of the biggest suppliers of mifepristone, are also two of the world’s leading drug exporters. They have about 500 manufacturing plants each registered with the FDA (it is unclear how many of these on-line sellers are among those registered).
The FDA is mandated to inspect these firms. However, according to Consumer Reports, the FDA needs additional staff to complete that task.
Links to some on-line pharmacies and sellers advertising mifepristone are now dead, but it is not known whether these are down due to government action or business problems.
Consumer Reports says that common issues uncovered by the FDA are “inadequate testing and quality checks, inconsistencies in data collection, and contaminated products.”
The situation (or competition) is so bad that even Women on Waves, one of the early proponents of clandestine chemical abortions, warns women,
Do not buy any pills from the website “Abortion-pill-online.com” or “mifepristone-misoprostol.com” or “mifepristone-online.com”. The medicines are not Mifepristone, Mifegyne or RU 486 as they claim. Women on Waves ordered and analysed them and the medicines that were sent to us did not contain the active ingredient Mifepristone!!! Do not order from the website “drugdelivery.ca” or “cytoteconline.com” either, the package never arrives!!!
This, while their partner website, Women on Web, directs women to their own Indian mifepristone manufacturer to order abortion pills for quick shipping worldwide.
While room does not permit detailed discussion here, many of these same companies and several others also manufacture their own generic versions of misoprostol, sold in the U.S. under the brand name Cytotec. This powerful prostaglandin is both commonly used in conjunction with mifepristone (to stimulate powerful uterine contractions to expel the child killed by the RU-486) and is also increasingly promoted and used as a stand alone abortifacient.
Why would anyone use or prescribe or even tolerate the use of misoprostol on its own? It is cheaper. Moreover it is easier to secure because misoprostol is already available in more countries because it has a legitimate medical use– people who take lots of non-steroidal anti-inflammatory drugs use misoprostol to help protect against ulcers.
Misoprostol is sometimes sold in a kit with mifepristone (RU-486) by some of these manufacturers (e.g., Sun’s Medabon, again, and the Antipreg Kit of Intas, and MTP Kit by Cipla). But misoprostol is also sold separately, sometimes under a new brand name, e.g., Aboprost, Misobort, Zitotec.
Exelgyn, the French firm that took over production of mifepristone in Europe in 1997, is now marketing three versions of misoprostol tablet packs – MisoOne, Topogyne, and Mispregnol. They say that these are to be used in conjunction with mifepristone, but the number of pills in a package (16) would seem to invite use as a stand alone abortifacient.
There is nothing to indicate that any of these new brands or generic versions of these abortifacients are in any way safer or more effective than the originals. There are substantial grounds for being concerned that they may prove as deadly for the mother as they are for the unborn babies.
But because the patents have expired, generic manufacturers can copy and produce the pills cheaply and sell them around the globe via the internet, with the international abortion lobby helping stimulate the market by promoting their use around the world, even in countries where abortion may not be legal.
With the manufacturer or distributor thousands of miles away, perhaps on an entirely different continent, and no real immediate professional medical help if something goes wrong, things could deteriorate quickly.
One doesn’t expect the packaging to mention the 19 women who died after taking mifepristone that the FDA knew about in April 2011(FDA, “Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011″). Most of those, we should note, were under a doctor’s care. That may not be the case with these generic drugs bought online.
Heaven help the pregnant mom who orders some strange sounding “abortion pill” from some manufacturer over the internet that hardly anyone has ever heard of before.
Shakespeare said that a rose “by any other name would smell as sweet.” Mifepristone, by any other name, would be just as deadly.
All Over the Map with Mifepristone
A few words about the chart. While every effort was made to be as comprehensive as possible, mifepristone is certainly being sold by more generic manufacturers and under more brand names than are shown here. We seemed to find more every time we tracked down a new source. We tried to match the spelling at the source, but there may be other spellings of same drug from the same company. The same drug may be sold under different names by the same company. We were unable to tell from the information available to us whether or how some of these companies were related. Some companies listed here may be manufacturers, others may merely be distributors or even marketing companies. Some may be partners, some may have common suppliers, some may get their pills from a subsidiary operating in another country under a different name. The country listed here is the home of the related company. Their pills may be sold all over the world or the company may have specific approval to sell or distribute pills in a particul
ar country or set of countries.
* The FDA recently approved Korlym (previously known as Corlux), a brand name for mifepristone, that can be used to treat patients with Cushing’s Syndrome, a condition where a tumor in the pituatary causes excess production of cortisol, which can lead to rapid weight gain, hypertension, high blood sugar, muscle and bone weakness, and cognitive disturbance. Packaging warns patients not to take Korlym if pregnant. While doctors may legally prescribe any approved drug for any purpose they see fit, it seems unlikely that a doctor will prescribe Korlym for abortion because of the high price for the drug, approximately $186 (wholesale) for a 300 mg pill. Mifeprex was selling for around $90 per 200mg pill.