August 2006

A reader informed me about the following curious omission.

On the FDA site it says:

3. What is Plan B?

Plan B is emergency contraception, a backup method to birth control. It is in the form of two levonorgestrel pills (0.75 mg in each pill) that are taken by mouth after a contraceptive fails or after unprotected sex. Levonorgestrel is a synthetic hormone used in birth control pills for over 35 years. Plan B can reduce the chances of a woman becoming pregnant when taken

Notice anything missing? The FDA also has a PDF of the product label and lists some other information.

There have been claims that this product only works as a contraceptive, yet the label says that it can prevent a fertilized egg (a.k.a. embryo) from implantation.

The insert that has the detailed information included with Levonorgestrel says:

The first line in an outright lie. If the egg is fertilized than the women is pregnant. The Columbia Encyclopedia says "period of time between fertilization of the ovum (conception) and birth, during which mammals carry their developing young in the uterus (see embryo)." This is just more of the intentional blurring of when conception occurs. Conception is not implantation. The same insert talks about the increased risks of Ectopic Pregnancies from Plan B. If implantation is the process of attachment of the embryo to the endometrial lining of the uterine wall and implantation equals pregnancy then they shouldn’t use the word Ectopic Pregnancy seeing implantation has not occurred because the embryo has settled in a location other than the uterus. They forgot to redefine pregnancy in these cases. I would be interested in what my readers think about this?

So which side is anti-science?

Christine at Ramblings of a GOP Soccer Mom has a typical example of media bias via truncation of a quote.

In another story Wesley J. Smith writes on Science by Press Release about the embryo destroying stem-cell extraction method that the media touted as not destroying embryos. The day this headline blared across the world I saw many blogger’s posting that something was fishy about this and that it did not jibe with the research printed in the Nature article.

Unfortunately, you can’t "honestly" say that. The above headlines–like Green’s statement and innumerable similar press accounts around the world–are just plain wrong. While ACT did indeed issue a press release heralding its embryonic stem cell experiment as having "successfully generated human embryonic stem cells using an approach that does not harm embryos," the actual report of the research led by ACT chief scientist Robert Lanza, published in Nature, tells a very different story. In fact, Lanza destroyed all 16 of the embryos he used, just as in conventional embryonic stem cell research.

And that’s not the only facet of Lanza’s work that the press got wrong. The ACT team did do something new: It worked with very early embryos, of 8 to 10 cells each, rather than the 100- to 200-cell blastocysts usually used in such research. From each of these early embryos, the scientists removed not one cell–as several press accounts reported–but 4 to 7 cells. This misreporting is important because it creates a materially false impression.

But the main stream press has editors and fact checkers so this couldn’t possibly have happened. I mean could they really print stories based on press releases without even reading the Nature article? Next you will try to tell me that Dan Rather would promote fraudulent documents to advance a story.

Wesley J. Smith goes on to show that ACT the company behind this has been guilty of press releases that didn’t match the reality of the research in the past. He relates two stories that received major coverage and laudatory coverage that did not pan out on later inspection.

The failure to report this story accurately amounts to massive journalistic malpractice–and once again ACT is laughing all the way to the bank.

Diogenes also links this press release to the performance of company stocks.

Victor at Rightwing film geek expands upon the same argument I made of the hypocrisy of having Plan B being OTC, but not the regular pill. Though he says it much better. [Via American Papist]

Let me see if I’ve got this straight:

* A daily dose of from 0.05 to 0.15 mg of levonorgestrel requires a prescription.
* Requiring that a 1.5 mg dose of levonorgestrel must have a prescription is patriarchal tyranny over women’s bodies, sexphobic anti-scientism and the precursor to a HANDMAID’S TALE-like theocracy.

That’s the unavoidable conclusion of this atrocious and politicized decision (courtesy of blackmail from "the mom in sneakers and the devil in Prada") to make available Plan-B "emergency contraception" over the counter. From Janice Crouse of Concerned Women for America:

Since birth control pills require a prescription and a doctor’s supervision during use, how can the FDA or the drug manufacturer condone providing Plan B (a mega-dose of the same drugs) over-the-counter? Widespread access to Plan B would expose women to the health risks that here-to-fore were acknowledged by doctors who screened women before prescribing birth control pills and then monitored them for the wide variety of contra-indicators for their use.

To be sure, in the first of the above-mentioned dosages, many forms of the Pill also have estrogen or something that mimics its effects. But it’s not as though progestins like Plan-B don’t pose real health risks quite on their own or that progestin-only oral contraceptives don’t also require prescriptions.

Today’s greatest winner — trial lawyers, who will soon receive a bountiful new field of cases, of people without medical training calibrating their use of drugs several times more powerful than what they need a prescription for when the stated purpose is something else (a fact that is chemically and biologically irrelevant). Mark my words — within the decade, Barr Laboratories will either be hiding behind immunity granted by a Democrat Congress, bankrupt/in receivership, or will have sold Plan-B to the government or some group like Planned Parenthood.

I think another possible fallout is that contraceptive pills could also become OTC at some point. The FDA simply can’t defend not doing this on medical grounds now that they have allowed this for Plan B.

WASHINGTON (Reuters) – Barr Pharmaceuticals Inc. won U.S. approval to sell its Plan B "morning-after" contraceptive without a prescription to women 18 and older, the company said on Thursday.

Younger girls still need a prescription for Plan B, Barr said in a statement. The Plan B pills may prevent pregnancy when taken within 72 hours of sexual intercourse.

The Food and Drug Administration approval follows more than three years of controversy. Backers and opponents of wider access had fiercely lobbied the agency, and the feud stalled the nominations of two FDA commissioners.

Plan B will be kept behind pharmacy counters, Barr said. The pills should be available in a dual nonprescription and prescription package by the end of the year.

"While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product," Barr Chief Executive Bruce Downey said in a statement.

Considering the President’s comments this week this is no surprise and seems to have been a done deal. Some commented that I shouldn’t jump the gun in my reaction in a previous post and they were probably right. Having your cynicism validated though is not something to cheer about. In a related story.

Federal regulators have not only cleared the way for over the counter sales of a morning after pill.

They’ve also eliminated the hurdle that threatened to sink President Bush’s pick to head the Food and Drug Administration.

Two senators who had blocked Andrew von Eschenbach’s nomination have withdrawn their objections since an FDA compromise was announced today.

The ruling lets women 18 and over buy the Plan B contraceptive without a prescription. Girls 17 and younger will have to have a doctor’s note.

Senators Hillary Rodham Clinton and Patty Murray say they still want the FDA to revisit the age restrictions. But their statement says the ruling is "real progress" toward giving all women access to emergency contraception.

Now since this is an FDA decision I don’t believe there is anything that can be done via either half of the house or the President. Of course since the President already knew the views of Acting Commissioner Andrew von Eschenbach he obviously approves of them when he put him forward to the Congress.

Republican Sen. George Allen was recently cited for having stock in Barr Laboratories Inc. the company that won permission for the OTC use of Plan B. He replied to this accusation by saying:

"I very much like them," Allen said after a campaign speech at a senior citizens home here. "It’s a good company. I don’t use their products, but it’s a good company that works hard in the community."