Correspondence
Correspondence GREECE AND TERRORISM IT SEEMS THAT NOTHING will Stop Wayne Merry from pursuing his questionably motivated and, by now, tiresome vendetta against Greece, portraying one of the safest...
...Every aspect of the safety, efficacy, and manufacture of Mifeprex was thoroughly reviewed and approved by the FDA...
...Results of the studies were peer-reviewed and published in the New England Journal of Medicine and the American Medical Association's Archives of Family Medicine...
...Last September, it signed a protocol of cooperation with the United States on combating organized crime and terrorism...
...Cooperation against terrorism must be more than words to achieve arrests...
...Danco's high praise of the RU-486 regime's safety is understandable, but hardly the final word...
...Despite Merry's obsessive defamatory campaign, Greece has one of Europe's lowest crime rates and will continue to care for the comfort and safety of its 12 million annual visitors...
...Contrary to what Kabbany implies, my story says nothing about the effect of misoprostol during the first trimester of pregnancy, when medical abortions are typically performed and when experts note that there is virtually no risk of a woman's uterus rupturing...
...As for RU-486's approval, it was conducted under FDA's Subpart H "Accelerated Approval of New Drugs for Serious or Life Threatening Illness"—a category that requires lots of stretching to make it include medical abortion...
...Kabbany has misrepresented my article and medical facts in a flimsy attempt to bolster her case...
...The drug has been thoroughly studied, both internationally and in the United States, and has been approved for use in 18 countries including the United States...
...The complications have included uterine rupture during childbirth...
...On the contrary, they had every reason to unearth such links, if they existed, but failed to do so...
...In Searle's words, it can cause "maternal and fetal death, severe vaginal bleeding, shock," etc...
...Without producing a single scrap of evidence, Merry insists on his outrageous claim that the reasons for the failure to crack down on the "November 17" terrorist group, responsible for 23 assassinations over a 25-year period, are political: that members of the governing socialist party are deliberately shielding former associates in the resistance against the 1967-74 dictatorship...
...The "November 17" terrorists have claimed 106 attacks...
...Judging from the public outcry and Greek media commentary, the Greek people are outraged by terrorism's toll in terms of human lives destroyed and reputations damaged...
...Regarding FDA approval of the drug, the article states that, "speed, rather than safety, seems to have governed the process of approving" mifepristone...
...government compilation for 2000 lists 115 politically motivated bombings and other terrorist acts in Athens, including the murder of British defense attache Steven Saunders...
...The U.S...
...Correspondence GREECE AND TERRORISM IT SEEMS THAT NOTHING will Stop Wayne Merry from pursuing his questionably motivated and, by now, tiresome vendetta against Greece, portraying one of the safest democracies of Europe as a haven for terrorists who will kill at random in the streets of Athens ("Where Terrorists Run Free," Feb...
...The clinical trials were sobering...
...My valid accusations concern political leaders who have brought shame on their nation by tolerating terrorists who could have been stopped years ago...
...DAVID GOODMAN Waterbury Center, VT I WOULD LIKE TO TAKE this opportunity to correct some of the misinformation that was reported in the article about the early option pill, which is used to end early pregnancy...
...The approval of the Mifeprex regimen was based on large-scale clinical trials conducted in France and in the United States...
...Indeed, the first "November 17" murders occurred during the 1975-81 period of a conservative government and continued during the 1990-93 period when the son-in-law of then-prime minister Constantine Mitsotakis was one of the victims...
...The murder of Saunders did inspire Greek revulsion and official promises of real cooperation...
...A reward of more than $4 million has been offered, confidential hotlines have been established, a public information campaign has been launched, and legislative changes foresee non-jury trials for terrorists and a witness protection program...
...clinical trials, and over 620,000 women in Europe have used this drug safely and effectively over the last 12 years...
...These problems stem from the widespread use of misoprostol at the end of a full-term pregnancy—38 to 42 weeks...
...A U.S...
...There is close cooperation as well with Scotland Yard and other European law enforcement agencies to deter trouble from any source...
...The accusation is absurd on the face of it, since the "November 17" terrorists have included members and premises of the socialist party among their targets during a period when governments of both major parties have alternated in power...
...As with any drug, Danco had to meet strict requirements for the manufacture of Mifeprex...
...Subpart H approval means Danco enjoys exemption from liability for adverse side-effects of its product...
...The tragic assassination last June of the British defense attache, Stephen Saunders, outraged Greek public opinion and was a turning point in Greece's determination to eradicate terrorism...
...We are treating it very seriously, not only because of the tragic loss of human life, but also because terrorism undermines Greece's national interests...
...In Iowa Dr...
...It is not my argument, then, that Goodman should complain about, but the manufacturer's...
...Greek police solved one, in the city of Thessaloniki...
...More than 2,000 women participated in the Population Council-sponsored U.S...
...Thirty drugs had previously been approved under this protocol: 17 for AIDS, 9 for cancer, and another for end-stage leprosy...
...Clearly, nobody in Greece is pleased that a singularly elusive small group of criminals, acting sporadically and in secrecy against targeted individuals, mainly Greek, but foreign citizens as well, have so far escaped arrest...
...IN "THE FDA AND THE ABORTION PILL" (Feb...
...In fact, 1996 was the same year we received an Approvable Letter from the FDA stating that the Mifeprex regimen was safe and effective...
...RICHARD HAUSKNECHT Danco Medical Director New York, NY JENNIFER KABBANY RESPONDS: Miso-prostol's (Cytotec) manufacturer, Searle, gives the strongest warning to doctors against using the drug to induce labor or abortion...
...Greek law enforcement has solved none...
...Mark Louviere treated one clinical trial subject who had lost more than half her blood and was near death...
...The distribution and manufacturing questions were answered to the satisfaction of the FDA, and the result was FDA approval four years later—hardly fast-tracking...
...At Danco Laboratories we spent many years working to ensure that Mifeprex met the FDA's safety and efficacy standards, that the manufacture of Mifeprex met both our standards and those of the FDA, and that we had a distribution system in place that would allow both access and safe use...
...National Commission on Terrorism identified 146 terrorist attacks against American interests...
...ACHILLES PAPARSENOS Embassy of Greece WAYNE MERRY RESPONDS: I do not attack Greece or its people...
...Also, in the context of a comprehensive security plan for the 2004 Olympic Games in Athens, the Greek government, in cooperation with the United States, is intensifying its anti-terrorist resources and methods to bring them up to the highest standards...
...5), Jennifer Kabbany cites an article that I wrote for Mother Jones to support her argument that medical abortions are unsafe...
...The FDA has repeatedly said, however, that drugs approved using this process must meet exactly the same standards of safety and efficacy as other approved drugs...
...Still, additional questions about the distribution and manufacturing process needed to be answered...
...We care deeply about the elimination of the terrorism scourge that has hit many countries around the world, including the United States...
...If Kabbany is forced to misrepresent her sources to make a case against medical abortions, it suggests that she has no credible evidence to cite in support of her conviction that this procedure endangers women's health...
...The approval of the Mifeprex regimen (mifepristone and a prostaglandin known as misoprostol or Cytotec) was not fast-tracked...
...What possible motive could these conservative governments have had to protect such killers...
...The authorities will not rest until the perpetrators are brought to justice...
...Mifeprex was approved under a set of rules used to establish distribution systems for drugs that the FDA has found to be safe and effective, and does allow for fast-tracking in some cases...
...RU-4RU-486...
...The murder of our defense attache, Navy captain William Nordeen, 12 years earlier, inspired a similar short-term reaction—but still no arrests...
...the FDA inspected our manufacturer and determined that Mifeprex has been manufactured to meet the current Good Manufacturing Practices of the FDA...
...These are serious complications that, if left untreated, could be lethal...
...We have been working since 1996 to receive FDA approval for the Mifeprex regimen...
...We are pleased to offer women in the United States this non-surgical option for ending early pregnancy...
...My article investigates the complications and lawsuits that have resulted from the routine use of the drug miso-prostol (Cytotec) to induce labor in pregnant women...
...It is important that women and their health care providers receive accurate information about Mifeprex...
...Out of 2,000 women, 8 percent suffered incomplete abortions and 5 percent "excessive bleeding," according to the New England Journal of Medicine...
...The Greek police record: zero...
...The company was created in 1995 to market and distribute one product— RU-486...
Vol. 6 • March 2001 • No. 24
