Readers Dissent About HHS and Plan B

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(See UPDATE at the end.) Let me try to work through some items today, naturally in LIFO order. Here are some sample notes disagreeing with my argument that the Obama Administration had swung to the "anti-science" side, when HHS Secretary Kathleen Sebelius overruled the FDA recommendation to permit over-counter-sales of "Plan B" pills to young girls.  First the complaints, then my reply.

One reader says: 

It's not really accurate to say "Anti-Science" because a) it is not clear that scientific tests have been conducted on 10/11/12 year old's of reproductive age to see what the side affects are, b) the panel aren't making a decision based on science if they are using precedence of other powerful drugs as a reason to permit it and c) public policy is ultimately determined by Government.

Sebelius isn't saying that the science is wrong, she's saying that they haven't done enough of it. They have not conclusively proven that there will be no side affects for a girl of any age if she takes this drug.

Lastly, once the science has been solidly established that doesn't end the discussion, it then becomes a moral issue for society to digest. Science does not dictate public policy. People and their morals do.

And:

I must disagree with you and others about this charge of the administration and President Obama.  I'm a father and have a precious daughter who will turn two in less than two weeks.
 
I'm also a fan of the President and will vote for him in 2012; I agree with him on this decision.  While science may be right, I just don't feel comfortable with allowing my daughter to have access to this medication especially if she's a minor (or younger than 18).  The analogy that the President used, having this medication, "next to bubble gum or batteries" is 100 percent correct.  This is not a question about science but a question about parenting.

And:

I believe that some clarification as to how the FDA and HHS are viewing Plan B and drugs in general could help shed some light as to why Plan B being widely available OTC is different than other OTC drugs on the market.  It probably has less to do with politics and more due to a different standard being applied by the two agencies.  With a standard OTC there can be a general assumption that there is some level of parental involvement for children.  An 11-year old child has little reason to purchase a drug like aspirin on their own, so its expected that its use will be monitored by an adult.

Plan B is different.  If there is a parent involved, then the parent can purchase it themselves and administer it to the child.  If a prescription is given by a doctor, there is an adult that can explain the proper use of Plan B to the child.  However, if it's OTC the intended use population for the drug changes.  You'd expect an 11-year old going to the store alone to purchase Plan B is doing so because the parents are not involved in the decision.  That's why the maker of Plan B, Teva, had to prove to the FDA not just that Plan B was safe and effective, but that adolescent girls understood how to use Plan B properly and that it's not to be used as a primary birth control before the FDA would allow it to be sold OTC.

However, what Teva didn't prove is highlighted by the HHS.  Teva didn't prove that the drug could be properly used by 11-year old girls, and 10% of girls start menstruating at this age.  The HHS takes exception to this, while the FDA probably had told Teva that 12 or 13 was good enough for a general OTC.  The HHS believes that there may be a significant cognitive difference between an 11 year old and a 12 year old which is why they rejected the application as a general OTC.

I'm not saying that there are no politics at play here, since that would be naive concerning Plan B.  However, to say that the HHS reasoning is anti-science is not a fair label either.

One more from a former public health official, then brief reply, after the jump.

I'm a retired public health epidemiologist (and scientist.). I'd like to explain that the Plan B contraceptive is one whopping dose of hormone -- the same hormones that are used in birth control pills and the same hormones that are associated with some types of breast cancer. I'd remind you that a 10- or 11- year old girl is just developing in terms of reproductive organs. I can tell you that there is NO evidence that it is safe for girls that age -- whose reproductive organs are not mature -- to ingest a very large dose of estrogen and progesterone. It is not known scientifically whether there would be any long-term effects.

Remember DES -- a synthetic hormone given to pregnant women whose daughters, years and years later, suffered numerous vaginal and other cancers as a result of their mothers taking the drug during pregnancy? [JF answer: yes of course I do.] In fact, please read a little about DES here: (or another, more scholarly source, if you will.)    Then please think about what is not known even now about unrestricted use of hormones.

 And there is much concern around the idea of hormones given to cattle and other animals and how that affects our food safety.  There is much opposition to health providers giving young boys growth hormone ( a form of male hormone) and testosterone to small boys or boys with small penis size. The concern is well justified.

So I am baffled at the idea that, on the liberal side, there is no evident concern about very young adolescent girls having free access to large doses of progesterone and estrogen. I can certainly understand, and support, the urgent need to interrupt a pregnancy in a very young girl.  But what about repeated use? What about unrestricted use? What about overdose? What about long-term, regular use?

I think that accusing people who raise concerns about this "anti-science" is completely unwarranted. It's not unwarranted to raise concerns about hormones in beef, but it's "anti-science" to raise concerns about 10- and 11-year olds taking large doses of hormones? It's not anti-science to raise concerns about excessive estrogen in Beluga whales, but in pre- pubescent girls it's anti-science?

Are you really helping the debate here?

To clarify my objection: I don't presume to be competent to judge the public health arguments about the risks of exposing young girls to more hormones, versus the risks of exposing some to pregnancies or abortions. And as I said the first time, the scientists who are competent to make those judgments are not automatically entitled to make larger ethical and political choices for society as a whole, or for families.

My objection was to the process and rationale for this decision.

The FDA panel was made of scientists who are presumed competent to weigh risks and tradeoffs like those the readers mention. I do not believe that Kathleen Sebelius -- for all her appeal as a politician and effectiveness as Secretary of HHS --  has technical standing to question the scientific basis for the panel's recommendation. But that was her purported reason for overruling it: that there wasn't enough evidence on certain points. If she had simply said that she understood the scientific argument for the recommendation, but that for cultural, ethical, personal, social-policy, or other reasons she could not approve it, that would have been different. Then you could agree or disagree with her decision, but you could not complain about her standing to make the choice she did.

Here's an analogy from the law. When appeals-court judges hear a case, they don't re-cross-examine witnesses. That's because they are supposed to take the facts of the case as settled by the trial court, and instead to think about questions of law. But Sebelius's claims about "lack of evidence" were comparable to a Supreme Court justice saying that he didn't trust a certain witness because "he had a shifty look in his eyes." That's not her call to make.

This is done, and for political reasons it may have been an unavoidable choice for the Administration, 11 months before election day. Which brings me back to the original point:  it was a political judgment and might as well have been presented unashamedly that way. Thanks for readers' views.
___
UPDATE: A reader points out that six years ago, when the Bush Administration's FDA recommended against expanded Plan B sales, another member of the current Obama cabinet, Hillary Clinton, made the "politics over science" point. As described in a NOW report:

The General Accounting Office (GAO) released a draft of its report on the decision in October. According to the Washington Post, the draft GAO report concludes that "the decision was highly unusual, was made with atypical involvement from top agency officials, and may well have been made months before it was formally announced."

Sen. Hillary Clinton (D-N.Y.) commented that the draft report "appears to confirm what we have suspected for some time: Science was compromised in the FDA's decision-making process on Plan B."
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James Fallows is a national correspondent for The Atlantic and has written for the magazine since the late 1970s. He has reported extensively from outside the United States and once worked as President Carter's chief speechwriter. His latest book is China Airborne. More

James Fallows is based in Washington as a national correspondent for The Atlantic. He has worked for the magazine for nearly 30 years and in that time has also lived in Seattle, Berkeley, Austin, Tokyo, Kuala Lumpur, Shanghai, and Beijing. He was raised in Redlands, California, received his undergraduate degree in American history and literature from Harvard, and received a graduate degree in economics from Oxford as a Rhodes scholar. In addition to working for The Atlantic, he has spent two years as chief White House speechwriter for Jimmy Carter, two years as the editor of US News & World Report, and six months as a program designer at Microsoft. He is an instrument-rated private pilot. He is also now the chair in U.S. media at the U.S. Studies Centre at the University of Sydney, in Australia.

Fallows has been a finalist for the National Magazine Award five times and has won once; he has also won the American Book Award for nonfiction and a N.Y. Emmy award for the documentary series Doing Business in China. He was the founding chairman of the New America Foundation. His recent books Blind Into Baghdad (2006) and Postcards From Tomorrow Square (2009) are based on his writings for The Atlantic. His latest book is China Airborne. He is married to Deborah Fallows, author of the recent book Dreaming in Chinese. They have two married sons.

Fallows welcomes and frequently quotes from reader mail sent via the "Email" button below. Unless you specify otherwise, we consider any incoming mail available for possible quotation -- but not with the sender's real name unless you explicitly state that it may be used. If you are wondering why Fallows does not use a "Comments" field below his posts, please see previous explanations here and here.
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