"FRC Lawsuit Accuses FDA of Politicizing Women's Health"

In a very interesting move, Family Research Council and Friends are suing the FDA over the dual-classification of Plan B as both prescription for people under 18 and over-the-counter for others. Here's the summary from an email I received entitled, "The Birds and the Plan Bs":

Last summer, the Food and Drug Administration approved the morning after pill, Plan B, for use as an over-the- counter (OTC) drug. However, they kept the drug's prescription (Rx) status for those under 18. This OTC-Rx split for the same product is unprecedented and illegal, and we said so at the time. Yesterday, the Family Research Council, Concerned Women for America, the Association of American Physicians and Surgeons, and others filed a lawsuit against the FDA asking that the U.S. District Court rescind the FDA's approval. Our complaint also states that Senators Hillary Clinton (D-N.Y.) and Patty Murray (D-Wash.) applied improper pressure on the FDA. Clinton and Murray placed potentially permanent "holds" on acting FDA Commissioner Andrew von Eschenbach's nomination to lead the FDA. After the FDA reversed its position on Plan B, the holds were lifted, and the nominee was eventually confirmed by the Senate. We also argue that Plan B's labeling is inadequate because testing revealed that only 67% understood that Plan B is not a replacement for regular methods of contraception. This suit marks the first time that FRC has participated in litigation to challenge an administrative agency's action we deem unlawful. To read more about the suit, which was featured in today's Washington Times.

The report from PR Newswire contains the main points of the complaint:

• The data submitted by Plan B's owner did not establish that it is safe or effective.
• The FDA lacks authority to approve the same drug for both over-the-counter (OTC) and prescription-only distribution.
• The FDA lacks authority to approve distribution based on the buyer's age.
• The FDA lacks authority to approve "behind-the-counter" -- a drug that is neither fully OTC nor prescription only.
• The FDA approved Plan B for non-prescription use without conducting the necessary rulemaking required by the Administrative Procedure Act and the Federal Food, Drug and Cosmetic Act.
• The sudden reversal by FDA and Commissioner von Eschenbach had the distinct appearance of resulting from improper political pressure exerted by Senators Clinton and Murray who made clear that they put "holds" on von Eschenbach's confirmation until he acted on Plan B.
• The FDA's approval ensures that girls will have unsupervised access to Plan B even though FDA has found that Plan B is unsafe for girls without medical supervision, as denoted by the fact it is prescription-only for those under 18.
• The FDA failed to require Plan B's owner to comply with the Pediatric Research Equity Act which protects children and adolescents.

While there's kind of the obvious (at least I think) possibility of an immediate dismissal for lack of standing (unless bringing suit against a government agency only requires citizenship in that government), this kind of appears to me to be a case of biting the hand that feeds. Weren't most of the FDA stallings and the end result of the prescription/OTC split directly due to the lobbying efforts of "pro-family" organizations and intervention by the Bush administration without which the drug may have been approved entirely for OTC use?

It will be interesting to see what kind of a response this gets from NARAL and Planned Parenthood as well as how many FDA personnel jump out their windows finally unable to take the schizophrenic nature of pro-family agencies' demands. Speaking of response, might there be any reason FRC decided to bury this on a Friday news-cycle? Or do they even consider it "burying" if their main constituency has a regularly scheduled weekend meeting, or two?

Links to:
The Washington Times--"Family groups sue FDA over contraceptive"
PR Newswire--"FRC Lawsuit accuses FDA of Politicizing Women's Health"
Download copy of the suit, as filed, from FRC's website

Kroger's exercise in futility

Kroger Response to Emergency Contraception

    ATLANTA, March 9 /PRNewswire/ -- The Kroger Co. believes that
medications are a private patient matter. Our role as a retail pharmacy
operator is to furnish medication using applicable professional standards
in accordance with a doctor's prescription or as requested by a customer.
    The Kroger Co. began carrying dual label OTC Plan-B in November of
2006, when the FDA approved it. It is our policy to carry the product in
all of our stores.
    If, for whatever reason, an individual pharmacist objects to furnishing
this or any other medication, our policy is to find a way to accommodate
the customer.
    We are taking additional steps to make certain that all of our pharmacy
teams have a clear understanding of this policy.

SOURCE The Kroger Co.

This press-release coming actually three days prior to Family News in Focus running a related story on their Monday news program: "NARAL Bullies Kroger over Abortion Drug." (Just to clarify: they're talking about Plan B, not RU-486.) The story actually quotes NARAL Georgia director, Dionne Vann,

“We’re seeing here that somehow these personal values are interfering with medical decisions made between a patient and their doctor,"

and goes on to supply a response from Sadie Fields, director of the Georgia Christian Alliance,

“If they object to any drug based on their conscience, how they feel or believe about it, then they have the right to not participate or to participate.”

FNiF goes on to report that Fields thinks NARAL is just "causing a stir."

“When they go after a corporation for making a corporate decision or after the individual store for making a decision that best suits their beliefs or what they want to do," she said, "then they’re going too far.”

According to a CNN story last Friday, a Rome, Georgia woman named Carrie Baker requested her local Kroger pharmacy to order the Plan B contraceptive, meaning, to actually stock the over-the-counter medicine at this one pharmacy (rather than the woman needing immediate access in order to deal with a pending situation). But even without the typical appeal to pathos, the case of this particular Kroger pharmacy (or specific head pharmacist) disregarding the company's stated policy is interesting for a couple reasons.

One: if the company-wide policy was to stock Plan B since November, why wasn't the drug ever shipped or supplied to this store in Georgia? The pharmacist would have either refused the shipment or refused to order a shipment---both of which should have aroused... well, something... and been addressed early.

Two: the pharmacist may have lied about stocking the drug, which would have violated the policy anyway (by not offering "accommodations" in the form of referral to substitute pharmacist or another pharmacy) and should presumably be subject to disciplinary actions by the company.

The FNiF broadcast incorrectly calls NARAL's action a campaign to force Kroger into changing its policy, which they state is: "to allow each store to make their (sic) own buying decision based on demographics,"(see above for the company's stated policy) but it would appear more accurate that NARAL is trying to assert that if Kroger is going to set a corporate-wide policy for the drug's distribution, Kroger and its pharmacies should follow it.

What FNiF does bring up correctly, however, is the Georgia state law regarding pharmacist's consciences. The law's Code of Conduct regarding this appears to be pretty clear:

Georgia Admin. Code § 480-5-.03
(n) Refusal to Fill Prescription. It shall not be considered unprofessional conduct for any pharmacist to refuse to fill any prescription based on his/her professional judgment or ethical or moral beliefs.

However, the Georgia Code of Conduct does not create any direct conflict to Kroger's stated policy of simply stocking the Plan B drug. If Kroger is going to be serious about following its own policy, it should, nay must do the right thing: stock the drug in its Rome, Georgia stores so that the pharmacists there can refuse to sell it to the customers.

The Jesus Machine of Colorado Springs

Dan Gilgoff, a senior writer at U.S. News and World Report, was a guest on NPR'sFresh Air with Terry Gross Monday morning to promote his new book, The Jesus Machine: How James Dobson, Focus on the Family and Evangelical America are Winning the Culture War.

I recommend listening to the show for a couple reasons: 1) Gilgoff has apparently "tagged along" with Dobson for some time now and really seems to know a good deal about FotF's impact on the 2004 presidential election via their Family Policy Councils at the state level (especially Ohio's). And 2) it's fairly entertaining to listen to Gross trying to coax answers and comments out of Gilgoff, who clearly prefers to let his typewriter do the communication stuff.

There wasn't really a whole lot of astonishing, new insight or jaw-dropping information divulged during the show, but the reviews I've seen so far for the book give me some hope that it isn't just another "My GOD!! Don't you realize these Religious Zealots are closing in on an American Theocracy!?!?!" book with Nazi references lovingly sprinkled throughout. To me, the genre of political/religious writing that espouses these and similar ridiculous statements do about as much good toward understanding or mutual respect as Ann Coulter writing Godless and calling anything that moves a faggot for attention. Divisiveness for divisiveness's sake will always be the lowest common denominator and, hopefully, someday we will all regard it as such.

So while the reviews give me at least a shred of hope in Jesus Machine (although that title's a bit hard to pull a positive spin on), I'll reserve judgement until I'm able to get a copy. If anyone who sees this has read it or plans too, you'll receive my sincerest gratitude for posting a quick summary of your reactions.

Follow up on Brownback's video game crusade

An email I received yesterday from Citizenlink contained, among other interesting items, a link to a new article regarding Sen. Sam Brownback's reintroduction of the "Truth in Video Game Rating Act." (By the way, for those who are interested: Sen. Brownback's most recent appearances on FotF and FRC Washington Watch Weekly were regarding "A deeper look at Christian Prosecution" and "Fostering a Pro-Life culture in the United States" respectively. A search of "Brownback" on the FotF site brings up 59 hits, mostly Citizenlink news articles related to pro-family legislature.) The "Truth in Video Game Rating Act" is intended to require the self-regulatory ratings agency known as the Entertainment Software Rating Board (ESRB) to "review the entire content of a game to ensure the accuracy of the rating."

From the Brownback website:
Currently game reviewers do not play the games prior to determining ratings. Their reviews are based on taped segments of the game submitted by the game's producer to the Entertainment Software Ratings Board. Such taped segments may or may not fully represent the game's content. The bill would prohibit video game producers and distributors from withholding or hiding playable content from a ratings organization.

In the Citizenlink article, Bob Hoose from Plugged In is quoted: "Based on recent ratings and content fumbles with games like Grand Theft Auto and Oblivion, there are obvious flaws in the system. When we review a game for Plugged In, we have to play through the entire game so we can give our readers as much information as possible. It seems that the ESRB needs to do as much."

This struck me as odd and a bit deceptive considering Monday and Tuesday's radio program guest, Bob Waliszewski, also from Plugged In, was cautious in regards to the magazine and website's forage into video game rating, stating that they didn't feel comfortable releasing a positive review for a game where only levels 1-4 were reviewed and deemed okay and then level 5 was where the violence and sex started (my paraphrase) and acknowledged the difficulty and level of "sophistication" required to review video games compared to movies or music. (See my previous post for more on these episodes)

A quick visit to the website shows that where "Movies", "Video/DVD", "Music", and "Television" have their own sections, video games must be searched individually. Probing further, a search of some popular titles, "Gears of War", "Halo", "Zelda", turns up another interesting item: from every review I was able to find, it appears games with people (i.e. not disjointed blocks falling rapidly) and any chance of violence or sex are rated poor or concluded with a message of caution. Yes, that's right. Plugged In appears to be hedging their rating "bets."

So basically, Hoose wants the ESRB to be more like his agency and just barely review a handful of games poorly. The problem that Hoose knows and Waliszewski admitted is that some games are just too long... and too hard... or can be hacked. Because of their "play through" policy, Plugged In can't keep up with the sheer volume of releases, and neither could the ESRB, and, while I do think companies who actively deceive a reviewing agency should be punished severely, user-created content and massive-multiplayer universes make it theoretically impossible to "play through the entire game," and "fumbles with games like Grand Theft Auto and Oblivion" should reflect poorly on the game's manufacturer (or horny end-users with programming skills, respectively), not the ratings agency.

So why the harsh criticism directed toward something the logistics of which Hoose and Brownback either have no comprehension (and would probably therefore not be competent to comment authoritatively on and propose legislature regarding, respectively) or else know to be imposing an impossible set of regulations? Well, I'll leave that up to you. But the kid in me wants to say, parents just don't understand, while the cynic in me thinks Brownback will be introducing a lot of go-nowhere bills this year that Citizenlink's news and emails will be more than happy to cover.

NARAL's got a new girl

It's a safe bet to say that Concerned Women for America's Jan LaRue does not like NARAL. I probably could have easily reached this conclusion before, on a recent edition of "Family News in Focus," she said NARAL's latest action surrounding an Ohio woman's failed attempt to procure Plan B from a local Wal-Mart pharmacy "smells like a fundraising ploy. I expect this whole campaign by NARAL to be filed appropriately in that infamous circular file we all maintain."

Well, fundraising it might be (actually, the NARAL email only contained "action links;" no donation buttons presumably until the website itself), but it's very unlikely that the campaign is a ploy. Tashina Byrd, the person, presumably does exist. Tashina Byrd, the ridiculed victim of Wal-Mart's unconscionable conscientious-objection policy (sorry), presumably did have some PR help. (Her on-the-spot, self-reflective response from the Jan. 15th Columbus Dispatch article was, "I could go to church if I wanted to be told how to live my life.")

The Family News in Focus story then detours from LaRue's snarky ad hominem to a now stock report on the ever-escalating war on pharmacists' consciences. FotF's own Carrie Gordan Earll (the extra 'L' is for Livid) is taken away from her real work just long enough to soundbyte, "The question is, is this really about choice, because if it’s really about choice, what about the choice of the pharmacist?"

Conscience clauses, call 'em "refusal clauses" if you're a lefty, have really only recently expanded from a doctor refusing to perform an abortion to a pharmacist refusing to supply an "abortifacient." I put that word in quotes because, as William Saletan wrote so well in a Slate article nearly one year ago,

"Who's right? Does EC kill some embryos, or doesn't it? The answer is, we don't know. We can't know..."

I'm going to refer to the same research Saletan uses to support the accepted theory that it is a very unlikely case that a fertilized egg's journey will be disrupted on its way to implantation due to EC. For evidence against this theory, you can look to Dr. Gene Rudd of the Christian Medical Association's somewhat deceptive reference to a 1999 literature review,

"Using conservative estimates, the study concludes that other mechanisms of action are at work up to 38 percent of the time. These mechanisms include post-fertilization effects—actions against a fertilized but not yet implanted human egg."

Keeping in mind that even if we accept the 8-year-old review's culled estimate of 38%, that estimate also includes every natural reason that an embryo fails to implant. So if the prevention of implantation by a newly formed embryo is the definite minority to the pill's main effectiveness of ovulation prevention, Family News in Focus should probably refrain from referring to EC as the "abortion pill." Maybe try out calling it the "abortion surprise pill." That may even be scarier.

The very heart of this issue truly is abortion. Shocking, I know. But as the idea of healthcare workers' "conscience clauses" move from personal philosophy to being actively legislated the actions of pharmacists and nurses who refuse to dispense potential abortions is being portrayed as civil disobedience, and the punishment from their employers is creating martyrs. In the past, the rights of the unborn have already been related to in the same manner as the civil rights movement, and by pushing those rights back from belonging to a fetus to belonging to an hours old, not yet implanted (or maybe never implanting) embryo, the Pro-Life movement is gaining attention and winning ground on an unexpected front.

Whether or not the public's focus is shifted from the virtuous pharmacist who never expected to someday be forced to park his morals and beliefs at the door, to stories of women like Tashina Byrd---a responsible woman, being responsible, denied access to her responsibility by an arrogant, unreasonable pill-dispenser---may determine the fate of "conscience clauses" for more than just pharmacists.

Just for fun: On the Family News in Focus episode I refer to, reporter Steve Jordahl mispronounces Tashina Byrd's name as Ta-nisha Byrd. I'm sure it was just an accident though and in no way reflects a FNiF stereotype.

Spoiler Alert

FotF today presents the first of a two-part episode entitled, "What parents need to know about video games," featuring special guests: Bob Waliszewski, director of the FotF ministry Plugged In (magazine and website; this month's issue features headline, "American Idol Worship"); Olivia Bruner, author of book, Playstation Nation; Bryan Hodges, a self-proclaimed former video-game addict.

The talk meanders through the various facets of gaming and stories that each guest presents: Waliszewski is concerned with what he sees as the escalating violence and sexualization of the industry (he's got a point---1972 vs. 2007) ; in the language of addiction, Bruner describes weaning her children off video games (one child is disturbingly quoted as saying, "There's no patch for Nintendo."); Hodges describes a downward spiral into anti-social behavior and tosses in a Columbine reference for good measure.

To be frank, FotF's take on video games is fairly disappointing. The line of evidence this episode serves up in heaping portions is essentially anecdotal with the kind of over-the-top scaremongering most people are already getting tired of hearing from their local news anchors. The problem with depicting gamers as lone wolves becoming more and more lost in their fantasy world of horror and graphic violence is that for every tragic story of deep-rooted pathology there is a counter-example. For a child-psychologist, in this episode Dobson does little to address the underlying environmental and personality problems that occur well before someone mimics video character behavior.

However, while this may be the first time in memory that FotF sides with anything coming out of Amsterdam, I bring up this episode in this entry because of a curious coincidence. I hate to set any kind of precedence so early in the blog's history, so let me issue a disclaimer: the author of this blog does not wish to deal in rumor, gossip, or conspiracy theory (unless I can somehow finish my work tying JFK's personal moon voyage to Area 51). That said, the coinciding of this episode, (the first after last week's FotF Valentine's Day weeklong tribute to marriage) and its warning of video game violence and addiction, to Republican senator and presidential candidate (and longtime friend of the program---he's made several appearances in the past, I'll try to post dates and topics as soon as I can) Sam Brownback of Kansas and his reintroduction of the Truth in Video Game Ratings Act last Wednesday is at least interesting. Interesting enough to keep an eye open. Nothing more though. I've already said too much.

Statement of Purpose

The purpose of this blog is observe, examine, and discuss the various subjects and issues of organizations whose stated purposes are to assist the family; provide advice on subjects related to the family; and to promote and defend the family through political change and influence on government policy. It is not to ridicule or denigrate the beliefs and people of these organizations. For the purposes of discussion, this blog assumes the premise that God exists, but it does not assume that God exists to make tax cuts permanent and to spread democracy across the middle east.

It is the hope of the author(s) (and hopefully the reader(s)) of this blog that by examining and approaching these subjects and issues from a skeptical, but open perspective, we may learn something about communication and encourage thoughtful consideration and debate amongst people from many backgrounds and beliefs.