Stephen D. Mumford, President of the Center for Research on Population and Security (CRPS) and chief advocate of quinacrine sterilization worldwide, has moved his stockpile of some 290,000 quinacrine pellets and 1,536 quinacrine-filled inserters “abroad” to “avoid conflict”1 with the US Food and Drug Administration (FDA). In a letter to FDA dated 4 November 1998, Mumford stated that he has decided to discontinue shipping pellets to researchers in the United States although he retained some pellets to use for “demonstration purposes at scientific meetings.”
Under federal law, as long as the supply remains abroad, the FDA will be unable to seize and destroy the unapproved drug, which Mumford has distributed for widespread non-surgical sterilization, especially of women in the Third World.
The letter of November 4 is Mumford’s response to an official FDA warning letter, dated October 14, 1998.2 That letter, signed by Bradford W. Williams, Director of FDA’s Division of Labeling and Nonprescription Drug Compliance, warned Mumford of possible “seizure, injunction, and/or criminal prosecution” if he did not comply with FDA’s request to “… immediately halt all distribution of any and all quinacrine under [his] control, identify its location, and voluntarily destroy it under the FDA supervision.”3
In a phone interview with PRI on 18 February 1999, Mumford claimed he moved the stockpile last August before he received the warning letter, and that FDA workers arrived at his home shortly after his response to verify the date of shipment. He said he would not “reveal the location” of the stockpile to “prevent opponents” (such as FDA) from “placing pressure” to stop its use and distribution. When asked if he will continue to distribute the drug for quinacrine sterilization (QS), Mumford answered “yes.”
An FDA official questioned the timing of the shipment, but declined further comment since the “case is ongoing.”
Burden of Proof?
In its warning letter, FDA identified quinacrine pellets as an “unsafe” and “unapproved new drug and a mislabeled drug in violation of the Federal Food, Drug, and Cosmetic Act.” Mumford’s response to this is that the burden of proof rests on FDA to show that quinacrine is unsafe. Further, he accuses the agency of distrusting the drug because of unfounded smear campaigns and conspiracies directed against it.
Usually, companies which seek to label and market drugs for new uses must run a gauntlet of scientific tests. Federal laws and regulations demand extensive testing of the effects, potency and toxicology of new drugs. So far, no American manufacturer has stepped forward to either test quinacrine or to make application to FDA on its behalf.
Mumford, in his response, suggests that FDA should not be concerned about this because “[m]any papers on QS studies published in peer-reviewed journals…can show that [quinacrine] is generally recognized as safe and acceptable.” However, peer reviewed studies cannot substitute for the rigorous testing FDA demands before certifying a new drug is safe and effective for use by the general public. Mumford also argues that “[T]he FDA does not have any scientific evidence to support the position that [QS]” can cause damage to a woman’s reproductive organs. “How can the FDA make such unsubstantiated claims which are accepted at face value by the uninformed?” he queries. But FDA’s warning letter merely points out that quinacrine pellets constitute an unapproved new drug, and that it has been mislabeled.
The Letter and the Law
Until recently, Mumford had stored his supply of quinacrine in the basement of his home in Chapel Hill, North Carolina.
In his response to the warning letter, Mumford wrote: “[W]e (CRPS) decided that we did not want to find ourselves in conflict with the FDA … and [decided] to move our supply of pellets abroad… . This was accomplished prior to receiving the [FDA’s warning letter].” He also wrote that he “decided not to ship any more pellets” to US researchers, adding, “[O]ur policy remains one of not shipping pellets in the United States… . Moreover, we will no longer ship pellets from the United States.”
Mumford questions FDA’s timeline of events concerning the stockpiled tablets. The FDA’s October letter refers to an earlier 24 September request (by telephone) that Mumford identity the location of his product inventory. In what seems to be a disingenuous response, Mumford writes: “[I] have never received anything in writing from the FDA concerning this matter.”
As long as Mumford supplies only foreign recipients with quinacrine from ports outside of the U.S., he will be unimpeded by the FDA in his effort to spread QS throughout the world.
Devastating to Deadly
Mumford has been an aggressive promoter of QS for years. Under his sponsorship, more than 100,000 Third World women have been irreversibly sterilized with quinacrine.4 Mumford’s remaining stockpile, wherever it is now located, could be used to sterilize as many as 20,000 more women.
The action of the unapproved drug has been described as follows: “Inserted directly into the uterus, quinacrine prevents pregnancy by scarring the fallopian tubes, No anesthesia is used, and the procedure is painful; some women faint. For many, short-term side effects include abnormal menstrual bleeding, backaches, fever, lower abdominal pain and headaches.”5
That QS permanently damages a woman’s reproductive organs is beyond dispute. Such damage is intended and almost always results in infertility. But quinacrine is also a potential carcinogen: “Longer-term consequences are less certain but potentially more ominous: independent laboratory studies in the U. S. indicate that quinacrine causes cells to mutate… [A]ccording to the World Health Organization (WHO) between 60% and 80% of known mutagens are also carcinogens.”6
More Concerns Cited
Earlier this year, FDA detained two lots of the unapproved drug on the docks when they were shipped to the U.S. Despite the FDA’s concern over its use, Mumford and his “partner” Elton Kessel appear poised to continue to distribute quinacrine around the world for use on unsuspecting women.
Mumford claims that FDA’s objections to quinacrine are an “abuse of authority” which “discourages” professional men and women from pursuing scientific careers.
“It is not merely the loss of American access to contraceptives that results from this abuse of authority by a handful of people at the FDA,” he writes. “[T]he whole American scientific community loses. Scientists leave in disgust and pursue other careers or become hopelessly cynical. Young scientists avoid the scientific enterprise altogether, choosing unrelated occupations instead.”
Mumford also responds that the FDA’s warning letter “seem[s] more like a press release that a letter written to communicate with me….”
“There is little doubt that your letter was written to undermine [a recent] 60 Minutes segment,” he states. Mumford also complains that the Warning Letter’s citation of the possible carcinogenic affects of QS were mentioned in that segment, “with destructive consequences.” He concludes: “Your journalistic coup… succeeded.”
A Catholic Conspiracy?
Mumford goes on to make even more radical charges, suggesting that the FDA is part of a Vatican-inspired campaign in the media against QS and him. He alleges that the World Health Organization, the Vatican and Population Research Institute have formed a conspiracy to thwart his mission.
In what has come to be a signature claim, Mumford asserts that the Vatican is behind the World Health Organization’s concern over QS.
Specifically, he charges that Dr. Patrick Rowe, of WHO’s Human Reproduction Program (HRP) is really a behind-the-scenes conspirator with Rome. Mumford’s evidence for this is that Rowe is a Catholic. When the massive Vietnam QS plan, which would have sterilized millions of women, was on the verge of being approved, Mumford writes “it was clear to QS opponents that the Vatican’s agenda was on the verge of a setback of gigantic proportions.” The Vietnamese government shut the “study” down after WHO persuaded Vietnam officials of possible cancer risks, he claims. According to Mumford, the Vatican/WHO conspiracy is linked through Dr Rowe.
“Vietnam … planned to perform millions of quinacrine sterilizations during the period 1994 to 1998,” Mumford admits. “Had this study been successfully completed by FHI, [QS] would have been on its way to becoming [a] widely used family planning method.”
Other WHO officials are named as co-conspirators as well. Mumford alleges that Dr. Earl Wilson, the first member of WHO HRP to oppose QS, has ties to the Vatican that run deeper than faith alone. Mumford’s proof is that Wilson “is the son of Pope Paul’s dentist. … The odds of this concentration of Roman Catholic males finding themselves in HRP by chance is less than one in one thousand.”
The alleged conspiracy has more than Catholic doctors, dentists and Popes in its ranks. Mumford admits that ordinary Indians, not Catholics, forced the Indian government to confront quinacrine’s deficiencies and to ban its use. But behind this grassroots opposition lurked none other than our own Population Research Institute. “[N]early all of the criticisms placed in the Indian press,” Mumford writes, “…first appeared on the web pages maintained by .. . the Virginia-based Population Research Institute one of the most significant sources of hate literature in the population field.”
Silence on the Salient Points
Although Mumford is extremely vocal in his criticism of the FDA, the Vatican, PRI and anybody else who has voiced criticism of QS, he skirts in silence human rights concerns.
Human rights organizations of all stripes have steadily opposed quinacrine’s distribution. In addition, Alix M. Freedman, writing in the Wall Street Journal, recently documented how Vietnamese women, who reported to clinics expecting to be given pelvic exams, found themselves sterilized with quinacrine instead. But Mumford, intent upon sterilizing the world, has no time for such concerns.
Meanwhile, Stephen Mumford and the FDA have reached a stalemate. Until someone collects the necessary data on QS, FDA will not grant approval. Without FDA approval, it is unlikely that any foreign drug approval agency will grant approval either. But Mumford has successfully spirited his quinacrine pellets outside the United States, and is free to distribute them as he chooses. This sad saga of quinacrine sterilization seems certain to continue.
1 Stephen D. Mumford, Letter to William Nychis, FDA Compliance Officer, 4 Nov. 1998.
2 Morrison, FDA “Lowers the Boom on Mumford,” Population Research Institute Review, Dec ‘98/Jan ’99.
3 Bradford W. Williams, Letter to Stephen D. Mumford, 14 Oct. 1998.
4 Freedman, “Population Bomb: Two Americans Export Chemical Sterilization to the Third World,” The Wall Street Journal, 18 June 1998.