Fox 31 reports about Plan B and the confirmation hearings of Dr. Andrew von Eschenbach, the acting commissioner of the Food and Drug Administration and President Bush's nominee to head the organization, contained multiple false and misleading statements.
In July 31 and August 1 reports about the emergency contraceptive pill known as Plan B and the confirmation hearings of Dr. Andrew von Eschenbach, the acting commissioner of the Food and Drug Administration (FDA) and President Bush's nominee to head the organization, Denver TV station KDVR Fox 31 made multiple false and misleading statements.
Opposition to von Eschenbach
In Fox 31's August 1 report on von Eschenbach's confirmation hearings, co-anchor Ron Zappolo wrongly reported that the scrutiny received by von Eschenbach over his handling of Plan B was “all because of his decision to back the controversial morning-after pill.”
From the August 1 broadcast of Fox 31 News at Nine O'Clock:
HEIDI HEMMAT (Fox 31 reporter): President Bush's nominee for -- to head the federal drug association is put under the microscope on Capitol Hill.
ZAPPOLO: It's all because of his decision to back the controversial morning-after pill. The nominee wants to make the contraceptive pill over-the-counter to women 18 and over.
VON ESCHENBACH: If they are going to use this particular emergency intervention safely and appropriately, I was willing to move forward with a final decision on your application.
ZAPPOLO: Several senators do not agree, saying his position on Plan B may cost him the job as head of the FDA.
First, contrary to Zappolo's report, von Eschenbach did not make a “decision to back” Plan B. Rather, on July 31, the FDA announced “it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals [the manufacturer of Plan B], to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option.” The Washington Post reported on August 1 that the FDA's “shift in position” -- which came after delaying over-the-counter approval of Plan B for more than two years -- “stopped short of a promise that the agency is ready to allow nonprescription sales of the drug.” Indeed, Eschenbach's July 31 letter to Duramed stated: “If after our discussions we conclude that the CARESM Program [Duramed's distribution plan] isn't sufficiently rigorous to prevent the OTC [over-the-counter] version of Plan B from being used by young girls who can't safely use the product without the supervision of a practitioner licensed by law to administer the drug, Plan B will remain Rx-only for women of all ages.”
Moreover, as the Post noted:
The letter from acting FDA Commissioner Andrew von Eschenbach to Duramed Research Inc. ... came just one day before von Eschenbach's Senate confirmation hearing, scheduled for this morning.
The timing led many of the drug's supporters, including several members of Congress, to discount the FDA's announcement as a political ploy timed to defuse what was widely anticipated to be a difficult interrogation of von Eschenbach.
In addition, contrary to what Zappolo reported, Senate Democrats have blocked von Eschenbach's confirmation as FDA commissioner and held up Bush's previous FDA nominee, Dr. Lester Crawford, because the FDA repeatedly has postponed a final decision on whether Plan B would be made available over the counter -- not because the FDA has recently decided to meet with Duramed.
In April 2003, Barr Pharmaceuticals applied to the FDA to make Plan B available over the counter to women 16 years and older. As Media Matters for America has noted, later that year, an FDA advisory panel voted 23-4 to approve Barr Pharmaceuticals' application, and FDA staff scientists recommended that the application move forward. Yet, in early May 2004, the FDA's Center for Drug Evaluation and Research (CDER) issued a "Not Approvable letter" rejecting Barr Pharmaceuticals' application. According to the May 8, 2004, edition of the Los Angeles Times, then-acting CDER director Dr. Steven Galson stated that the reason for the rejection was “that not enough was known about the possible effects of the pills on the sexual activity of young girls.”
According to a March 30 Congressional Quarterly article, “Barr reapplied in July 2004 to make it available behind the counter at drugstores and only to women who showed proof they were 16 or older.”
Senate Democrats then delayed the confirmation of Dr. Lester Crawford, Bush's prior nominee to head the FDA, until he promised to set a deadline on the FDA's consideration of whether to allow Plan B to be sold over the counter. Crawford was nominated to be FDA commissioner on February 15, 2005, but his nomination was blocked until July 2005 when, according to a July 19, 2005, Washington Post article, the Senate confirmed him after he promised to issue a decision on Barr Pharmaceuticals' application by September 1, 2005. In August 2005, Crawford announced that the FDA is “taking the action of publishing an advance notice of proposed rulemaking to initiate an open public process to consider these important regulatory and policy questions.” Crawford resigned on September 23, 2005.
In September 2005, Bush appointed von Eschenbach as acting FDA commissioner and, on March 15 of this year, von Eschenbach was submitted to the Senate for confirmation to head the FDA. Congressional Quarterly's March 30 article reported that Sens. Hillary Rodham Clinton (D-NY) and Patty Murray (D-WA) vowed to block von Eschenbach's confirmation unless the FDA made a decision on Barr Pharmaceuticals' application to sell Plan B over the counter. From the March 30 Congressional Quarterly article:
Immediately after President Bush tapped Andrew von Eschenbach to lead the Food and Drug Administration in March, the two senators placed a hold on the nomination, making clear they intended to lift it only after the agency decides on an application for over-the-counter sales of the drug.
The stalemate on Plan B may have sunk any chances of getting a permanent commissioner for the near future.
If the agency approves the drug, as its advisory committee recommended, it is sure to upset the conservative wing of the GOP. If the agency denies it, the administration will be vulnerable to accusations of allowing politics to interfere with science.
Murray and Clinton met with von Eschenbach on March 28, and afterward reiterated their intentions.
“We will keep our hold on his nomination despite the fact we very much want to have a permanent director of the FDA,” Clinton said.
“If they think the issue is going to go away, they're wrong,” Murray said.
On August 2, The New York Times reported that Clinton and Murray said they would continue to block von Eschenbach's confirmation:
Senators Patty Murray of Washington and Hillary Rodham Clinton of New York, both Democrats, have held up the vote on Dr. von Eschenbach's nomination until the agency issues a decision -- pro or con -- on the over-the-counter sale of Plan B. They said Tuesday that they would continue that hold; with the Senate unable to vote on the nomination, the Health, Education, Labor and Pensions Committee, which held the hearing, did not vote after the nomination hearing.
Mrs. Clinton said that Dr. von Eschenbach, a former director of the National Cancer Institute, was eminently qualified for the job, but that his nomination had to be stalled because of Plan B and the larger debate it had come to represent.
''Like so much of this government in the past five and a half years, it has been turned into a political football, and you're on the field,'' Mrs. Clinton said. ''This is not just about Plan B. Once we start politicizing the F.D.A. there is no stopping. It is essential that we draw a line, and we are drawing a line right here.''
Fox 31's July 31 report on Plan B was also misleading in that an unidentified reporter stated: “The government had already agreed that it was safe to sell over the counter to adults, but kept delaying a decision out of concerns that teenagers might have access to the medicine.” The implication was that the drug is potentially harmful to teenage girls.
While it is true that the FDA has stated that Barr Pharmaceuticals “did not demonstrate that Plan B could be used safely by young adolescent women for emergency contraception without the professional supervision of a licensed practitioner,” Fox 31 failed to inform viewers that studies have found that Plan B is safe for adolescent women.
On May 27, 2004, the American Academy of Pediatrics and the Society for Adolescent Medicine issued a joint letter to the FDA urging the agency to reverse its decision on the grounds that "[t]here is adequate safety information about the use of emergency contraceptives both from Barr Research Inc.'s supplemental new drug application and data associated with long-term prescription use of these agents in the adolescent population." The letter also pointed out that "[a]pproximately one-fifth of the participants in the Barr trials were between the ages of 14-16, which represents ages below or consistent with the average age of first intercourse." On September 6, 2005, The Washington Post reported on another study published in the journal Obstetrics and Gynecology that “suggests the treatment is safe for adolescents and younger women.” The article quoted one of the study's co-authors, Dr. Philip Darney, chief of obstetrics and gynecology at San Francisco General Hospital, saying, “We didn't find, with regard to health issues, that younger women were any different than older women.”
The FDA's May 2004 denial of Plan B for over-the-counter marketing status became the subject of a Government Accountability Office (GAO) investigation, which found that the FDA's decision, based on “the propensity for younger adolescents to engage in unsafe sexual behaviors because of their lack of cognitive maturity compared to older adolescents,” was unprecedented in that “there are no age-related marketing restrictions for any prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them.” The report also pointed out that the “FDA identified no issues that would require age-related restrictions in the review of the original prescription Plan B new drug application.”
Claims that Plan B may cause abortion
During the same July 31 Fox 31 segment, the same unidentified reporter stated: “The drug works by stopping ovulation, or if the egg has already been fertilized, it increases the chance that it won't attach to the uterus. Critics charge that is abortion. But advocates disagree, saying if a woman is already pregnant, the pills have no effect.”
It is true -- as “advocates” point out -- that Plan B has no effect if a fertilized egg has already been implanted in the uterus. The FDA's “Questions and Answers” Web page on Plan B states: “If a fertilized egg is implanted prior to taking Plan B, Plan B will not work.” But in portraying the question of whether taking Plan B is akin to having an abortion as simply a debate between “critics” and “advocates” of the drug, Fox 31 failed to inform viewers that, according to the medical definition of abortion, Plan B cannot cause one.
According to Dictionary.com, Merriam-Webster's Medical Dictionary defines “abortion” as “the termination of a pregnancy after, accompanied by, resulting in, or closely followed by the death of the embryo or fetus.” While some opponents of Plan B argue that pregnancy begins when an is egg is fertilized, that argument is contradicted by the Department of Health and Human Services (HHS), of which the FDA is a part. HHS defines “pregnancy” in the Code of Federal Regulations as “encompass[ing] the period of time from implantation until delivery.”
As a July 2006 paper by Princeton University economics professor James Trussel and Drs. Felicia Stewart and Elizabeth G. Raymond explained, “ECPs [emergency contraceptive pills] do not interrupt an established pregnancy, defined by medical authorities such as the United States Food and Drug Administration/National Institutes of Health and the American College of Obstetricians and Gynecologists as beginning with implantation. Therefore, ECPs are not abortifacient.”
However, even if one were to accept the argument of Plan B's opponents that pregnancy begins at fertilization, there is still significant doubt -- unmentioned by Fox 31 -- about the likelihood that Plan B would prevent implantation of a fertilized egg.
According to the FDA, there are three possible ways in which Plan B could work, the last of which some of Plan B's opponents consider abortion:
Plan B works like other birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation).
At least one study, published in the December 2004 issue of the journal Contraception by reproductive physiologist Horacio B. Croxatto of the Chilean Institute for Reproductive Medicine in Santiago, Chile, has cast doubt on whether Plan B actually might work by preventing implantation. A press release summarizing Croxatto's study, which was performed on female rats, monkeys and humans noted that the study concluded that “emergency contraception using levonorgestrel [such as Plan B] works by disrupting ovulation, not by interfering with implantation.”
Referring to Croxatto's conclusion, Trussel, Stewart, and Raymond's July 2006 paper stated:
It is unlikely that this question can ever be unequivocally answered, and we therefore cannot conclude that ECPs never prevent pregnancy after fertilization. Even if there were an accurate test for fertilization, a finding that some fertilized eggs do not implant after ECPs are taken would not mean that ECPs can work after fertilization, since many if not most fertilized eggs naturally do not implant. Nevertheless, even if in some cases ECPs work by inhibiting implantation of a fertilized egg, these probably would be outnumbered by other cases where fertilization of an egg that would not have implanted naturally is prevented because ECPs inhibited ovulation.
From the July 31 broadcast of Fox 31 News at Nine O'Clock:
ZAPPOLO: A surprising decision that could clear the way to allow over-the-counter sales of a morning-after pill to women 18 and over.
DEBORAH TAKAHARA (co-anchor): And tonight, some are questioning whether it's medicine or politics behind this controversial decision.
UNIDENTIFIED REPORTER: The drug is called Plan B, and it's already available with a prescription. However, for about 3 years, the company has been trying to get permission from the FDA to sell it over the counter.
Plan B contains a high dose of the ingredient currently in traditional birth control pills. When used within 72 hours of unprotected sex, it can lower the risk of pregnancy by almost 90 percent. Advocates say it's often difficult for women to get a prescription filled so quickly.
UNIDENTIFIED ADVOCATE: Timing is very key here and this will make it much more accessible. Accessibility is a key issue.
UNIDENTIFIED REPORTER: The drug works by stopping ovulation, or if the egg has already been fertilized, it increases the chance that it won't attach to the uterus. Critics charge that is abortion. But advocates disagree, saying if a woman is already pregnant, the pills have no effect. The government had already agreed that it was safe to be sold over the counter to adults, but kept delaying a decision out of concerns that teenagers might have access to the medicine.
TAKAHARA: The announcement comes just 24 hours before President Bush's nominee to lead the FDA was to appear before Capitol Hill lawmakers. At least two of those lawmakers say they will continue to block the nomination until the pill is approved.