• The standard of safety

    In defending the Plan B decision yesterday, President Obama said the following:

    “And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old, going to a drugstore, should be able, alongside bubble gum or batteries, be able to buy a medication that potentially if not used properly could end up having an adverse effect,” Obama said. “And I think most parents would probably feel the same way.”

    So let’s examine that statement. It seems pretty reasonable on its face. Sure, the FDA may have evidence that the drug, when used properly, is safe and effective. But how can we be assured that adolescents will not go crazy and start popping Plan B like candy. If only someone had studied that possibility.

    If only the administration had read their FDA commissioner’s statement:

    The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

    See, as part of the review process for making a drug over the counter, the CDER specifically investigates whether that would be a problem. They study whether patients can understand how to use the drug properly without a healthcare provider being involved. They check if patients understand the labeling. They examine whether patients understand how often to take it. And, in this case, the CDER did all of this with adolescent girls.

    If Secretary Sebelius, and President Obama, feel that this CDER review was improperly done, they should say so. If they feel the investigation was flawed, or incomplete, it is up to them to explain why. But in their response, they seem to be pretending that it never occurred.

    Moreover, this is the process by which all over-the-counter drugs are approved. All drugs, when improperly used, carry significant effects. In 2009, there were over 70,000 calls to poison control centers for concerns about acetaminophen and more than 88,000 for ibuprofen. More than 30,000 calls were made for diphenhydramine, and 4 of those cases resulted in deaths. Just looking at kids 5 years of age and under, there were more than 130,000 calls for analgesics, 53,000 for vitamins, 48,000 for antihistamines, and 45,000 for cough and cold preparations. And yet, no one seems to be too concerned that these medications could be purchased “alongside bubble gum and batteries”. And, for the record, battery ingestions killed 4 kids in that age group that year.

    All drugs are potentially dangerous. I don’t think that 11 year olds should be buying Tylenol, or Ibuprofen, or Benadryl any more than I think they should be buying Plan B. Maybe we should set age limits for the purchase of all over-the-counter drugs; but we don’t do that. We have set rules as to what is considered safe for over-the-counter sales, and we have determined that the societal good of having those drugs available without a prescription outweighs the very real and known harms that they pose. If the current administration is going to take the unprecedented step of over-ruling the FDA for this one drug, I would hope that they have a compelling reason to believe that it is more dangerous than all those that came before it. I would hope they have some data behind them.

    Otherwise, this administration is letting politics trump science. And while it may make campaigning in some ways easier next year, it will remove a significant amount of credibility that they are the ones who will shield science from politics.

    AEC

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    • Kudos to you for your consistency when it comes to supporting science over political expediency here.

    • I’d side with the FDA given that we don’t have free medical clinics available to any woman who might want/need Plan B. However, there are misuse issues that go beyond those for painkillers and antihistamines that were pretty well illustrated (accidentally? don’t know) in an episode of The Walking Dead a few weeks ago. Ideally, women taking Plan B should be provided pregnancy tests before and after and specifically told how it works and what it doesn’t do, right? There’s a danger in walking around not knowing your pregnant that’s not associated with having headache or stuffy nose. But we don’t live in an ideal country by any stretch… OTC with strict regulations regarding material included with the pills is probably the best feasible option.

      I agree that it’s ridiculous to claim this is done for the safety of 10- and 11-year-olds, as Obama & Sebelius have done.

    • @Dr. Carroll–

      Thank you for this post. I commented on your original post regarding Plan B, asking for additional clarity on your analysis regarding the administration’s actions. This post includes the critique I had been hoping to get in the original post. I appreciate that you gave a clearer expression in this post of why the Obama administration is not justified in this action and agree with your points 100%. It is unfortunate when politics trump good policy. It is even more unfortunate when the political gain being attempted probably will not be achieved. I suspect that this action will turn off more of his supporters (suppressing his base) than it will encourage “persuadable” voters to support him–making this action a lose/lose proposition (bad policy and bad politics).

      zzz

    • I thought “over the counter” meant you had to ask the pharmacist for the product. Isn’t it their job to make at least a brief evaluation of the purchaser, and to advise them on the correct use of the drug, possible side effects, other concerns, etc?

      • No. It means you don’t need a prescription. It’s terrible terminology. http://en.wikipedia.org/wiki/Over-the-counter_drug

        • I don’t know if it’s the same in the US but in Canada there is a significant selection of drugs that are non-prescription, but require you to ask the pharmacist for the product. When you ask, they do as I described above… that is, ask you for what purpose you want it, have you taken it before, do you have any related allergies, are you on any other medication that may interact, etc.

          Is there any reason why that couldn’t be done in the US? Or are pharmacists just glorified pump jockeys when it comes to non-prescribed meds? If so, that would seem a waste of their talents.

    • There is a whole other study opportunity here of parental perception of what is and is not safe for their kids. There is a misunderstanding most parents cherish that if their child needs birth control of any kind they will talk to their parents about it. Most teens I work with don’t understand how their body works and have a huge capacity for denial about bad outcomes.

      I wonder if the calls to poison control centers for other OTC products doesn’t suggest that pharmacists should have a larger role in their distribution? Knowing how few people utilize prescriptions as written suggests that people shouldn’t have access to most OTC medications without some kind of guidance. Including written instructions assumes not only literacy of the recipient but intent to use and ability to understand. The fact that so many previously prescribed products are available OTC does not suggest to me that they are actually safe, but that the combined interests of the manufacturers to increase sales and patients to avoid medical expense trumped a rational consideration of human behavior.