So apparently morning-after pills don’t prevent implantation after all? (Which matters because that’s the reason abortion opponents hate them. Or say they do.)

Nurse: Oi vey! I feel like every time we open up a discussion like this, I
put on my sarcastic hat and say something like, “what, does pregnancy
begin at ovulation now, no sperm required?” and then the religious
right is like, “yes, actually, it does.” and then my head explodes and
something inside me dies.

Lawyer: That’s right. We’re all pregnant right now. In fact, we’re born with eggs,
so maybe we’re born pregnant?

Nurse: So now, if, as this article suggests, EC pills actually stop fertilization rather than stopping implantation, you’d think that would make things better, wouldn’t you? I guess my
point is that. . . well, they probably won’t. Whatever the quibble was this time, there will be something else, seemingly unthinkable, to take its place. Such is the nature of this debate. It’s not reasonable or logical.

Lawyer: True, but it’s often couched in those terms. So I think there’s value in
continuing to expose flawed logic. To protect the integrity of logic, if not to win on the actual issue.

Nurse: OK, Mr. Spock!

Lawyer: Plus, there are plenty of people out there who are swayed by logic. So, the
super-fringe will hold fast no matter what. But I have to believe there are people who will listen to reason, or reasonable-sounding things, such that that battle is worth fighting.

Nurse: In terms of the labelling, we sell all kinds of drugs that work without completely understanding the mechanism, and that is all fine and dandy and perfectly legal, right?  Also, the FDA may not really be a great source for cutting-edge science– they are the sanctioned authority, but not necessarily “right.”.

Lawyer: Agreed. What I think is really fascinating here is the power that one line
of an FDA label had. We’ve seen this fight play out a bit with the question of over-the-counter morning after pills, too — a good deal of the debate ends up being about
what’s on the label. But there seems to be a disconnect between how those things get designed and the immense ripples they can create.

Nurse: Finally, I always think it’s interesting when science may be influenced by religion and politics. Who is funding, or suppressing, research? Who knows?

Lawyer: Tell that to Secretary Sebelius.

Nurse: No, ma’am, I don’t like it!

“Smart Choices” Program ain’t so smart…

Lawyer: I have surfaced from an intense week of law school and have finally found a few minutes to look at the news. Man, this stuff raises my blood pressure. Much more than these crazy-heavy casebooks.

The New York Times is running an article about the new “Smart Choices” labeling on packaged foods. Basically, it’s a group of industry folks agreeing on standards for putting this checkmark on food packages. Controversy is arising from the fact that Froot Loops, among other classics of the junk food genre, are getting the check-mark.

It includes the following quote:

“Dr. Kennedy, who is not paid for her work on the program, defended the products endorsed by the program, including sweet cereals. She said Froot Loops was better than other things parents could choose for their children.

“You’re rushing around, you’re trying to think about healthy eating for your kids and you have a choice between a doughnut and a cereal,” Dr. Kennedy said, evoking a hypothetical parent in the supermarket. “So Froot Loops is a better choice.”

Now, I know I’m currently studying for a profession that places a premium on logic. Yeah. I get that. But don’t tell me that med school completely discounts it. If they’re really using this standard, then they might want to make the label say something like “All but the very stupidest choices.” I mean, okay. Let’s see. Cigarettes are smarter than heroin. Green checkmark! A Ford Expedition is smarter than a Ford Excursion. Checkmark!

This campaign is misleading and seems like an attempt by food manufacturers to get themselves off Michael Pollan’s shit list when they don’t deserve to be.

Can they do that? Well, yeah, for now, they can. The FDA says they’ll monitor it — and maybe, if it seems to be influencing people’s food choices in a negative way, they’ll think about it more. Can they do more than that now? Should they? It gets more complicated when you look at the fine print — companies are paying to participate in this program. So Kellog’s pays to have that label on its boxes (though it can only put the label on products meeting certain criteria.)

A much better solution: The FDA (whether in its current form, or split into an FA and a DA, as we’ve discussed before) would provide its own labeling system, with more sound criteria, that would uniformly apply to all food products, not just those who had the money wanted to pay to sound healthier than they are.

The Food Administration

Lawyer: The New York Times was running this headline on their website yesterday: “U.S. Food Safety No Longer Improving.”

Um, thanks guys. I think most of us can see that, what with all the salmonella and e. coli. (By the way: pistachios? Really? Say it ain’t so!)

The article highlights some in-fighting in food safety regulations — the Department of Agriculture and the FDA seem to be having a lot of fun pointing the finger at each other.

In an earlier post, we talked about the possibility of splitting the FDA into a food agency and a drug agency — wouldn’t that solve some of this problem? Especially if that food agency took over some responsibilities from the aggies in terms of food safey? It might still be an oversized, under-effective agency, but at least it would be focused on one area, rather than sharing a budget with clinical trials, medical device, and drug regulation.

White House: DO IT.

Ping-Pong Post: FDA Commissioner

President Obama has nominated a commissioner for the FDA. And a deputy. (The commissioner needs senate confirmation, but the deputy does not.)

Lawyer: Basically, the only people I’ve come across on the web who are anti-Hamburg are pro-life zealots who tag her as a pro-abortion type person. She isn’t inflammatory in any way, she has a great resume, accomplished good things in NYC – what’s not to like?

Nurse: And even if she is pro-abortion, she probably doesn’t have a lot of swing from the FDA. There are issues that cross over, sure, but she can’t legalize abortion this way.
It’s great to have someone with real public health experience, on the ground, up for this post. In addition to the administrative skills and politics, it’s key to be able to understand large-scale ramifications of health projects and initiatives and how they can work in the public arena. A great example of this is her implementation of directly-observed therapy for TB patients– recognize a problem, implement a solution, examine the results– and it has been wildly successful.

Lawyer: Also appointed: Josh Sharfstein as chief deputy. A pediatrician with a record of fighting for safety of OTC cold and cough medications.

NYT points out that this looks a little like he might be considering splitting the FDA into a food agency and a drug agency. Which might make sense – one of the chief cited problems with the food regulation process is that there are too many separate agencies involved, so if the FDA split in two, maybe the food half could better absorb or oversee all the food regulation functions happening in other agencies (e.g. Dept. of Ag.)

Also happening: creation of a food safety working group.Food safety has become a really big issue in the last five years, and Obama is making a clear push to improve it.That’s a nice, safe issue –who’s opposed to food safety? Any nurse thoughts?

Nurse: Food safety is great! Clearly it’s an issue for us (salmonella, e. coli, peanuts, spinach. . . really.) I think it’s also a good idea to find ways for food safety groups to interact with agriculture and trade in a high-profile way– none of this is islolated!

Lawyer: And aren’t food safety and drug safety really two very separate things? What else might a food-specific agency do? More outreach about nutrition? Regulating genetically modified foods?

Nurse: Yes, they are extremely different! The same agency currently deals with peanut scares and cancer trials. And they share funding. That doesn’t seem. . . good.

Lawyer: Mr. President man, your regulatory agency strucutre is not… good.  Let’s split it! Then you just have to decide where certain things would fall. Supplements? Cosmetics? Etc…

Nurse: Perhaps this would be an opportunity to assign these things better ways of being regulated. Supplements are notoriously poorly regulated, and cosmetics are always toeing the line, especially recently, into making medical claims. I think splitting the agency would perhaps be an opportunity to  make some changes in how these things are regulated.

Lawyer: Wait, you mean wearing mascara doesn’t *actually* make me younger?

Anyway, seems like a good idea to me – these two functions can be recognized and funded (sigh) separately. And each could go more in-depth if one person wasn’t trying to oversee it all.

Are we moving toward integrating the FDA more into our nation’s public health structures? How can the FDA do more as regards public health?

Nurse: A lot of public health stuff happens very locally and isn’t well funded. I think there’s a lot of reinventing the wheel, too– maybe this would help with that, but I think also that the office of the surgeon general (new nominee yet?) will be able to step up to the plate here!

Lawyer: Nothing official, but here’s a possible nominee. You should like her, nurse.  She’s a nurse AND a doctor.

A lot of things that are good for public health are getting cut now (R.I.P. Healthy Families). I think it needs to stay on our minds!